Esophageal CancerPhase 2NCT00525915
Oxaliplatin-Based Chemotherapy and Chemoradiotherapy or Chemoradiotherapy in Esophageal or Gastroesophageal Carcinoma
A Phase 2 study testing 5-Fluorouracil, Oxaliplatin and Radiation Therapy in people with Esophageal Cancer and Gastroesophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Esophageal Cancer, Gastroesophageal Cancer
- What is being tested?
- 5-Fluorouracil, Oxaliplatin and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Mar 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.
- Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.
- Normal liver (serum glutamic-pyruvic transaminase (SGPT) < 56µL, Total Bilirubin <1.5 mg/dL), kidney (Creatinine <1.75 mg/dL), and bone marrow functions (AGN >1,500µL, platelet count >100,000/µL).
- Performance status 0 or 1.
- Signed informed consent by the investigator or their designee and patient.
- Medically fit for surgery.
Show all 14Show fewer
- No Celiac (except for the GE junction cancers), supraclavicular, or paraaortic nodal enlargement unless biopsy negative.
- None of the celiac nodes should be larger than 2 cm
- Male or Female but both sexes must practice adequate contraception while on therapy
- >/=18 years but less than 76 years
- No known allergy to any of the study drugs.
- No prior therapy for this cancer.
- No significant cancer (defined as non-melanomatous skin cancers and treated cervical cancers) within the past 5 years
- New York Heart Association (NYHA) I and II
Who cannot join
- Patients with T1N0, T4, or M1b cancer will be excluded
- Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).
- More than grade 1 neuropathy
- Unable to comprehend the requirements of the study or comply with it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Oxaliplatin-Based Phase II Randomized Study of Induction Chemotherapy Followed by Preoperative Chemoradiotherapy or Preoperative Chemoradiotherapy in Patients With Resectable Esophageal or Gastroesophageal Carcinoma
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared.
Objectives:
Read more
Primary objective:
Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in the resected surgical specimen between Arms A and B.
Secondary objectives:
- Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B
- Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
- Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.
Read the detailed description
Oxaliplatin and 5-FU are chemotherapy drugs that are commonly used to treat certain kinds of cancers. 5-FU is designed to prevent cells from making DNA that is necessary for cell growth. This disrupts the growth of the cancer cells, which causes the cancer cells to start to die. Oxaliplatin is designed to damage DNA that is already formed.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in the first group (Arm A) will receive chemotherapy with radiation treatment. Participants in the second group (Arm B) will receive chemotherapy first then chemotherapy with radiation treatment. The chemotherapy that will be used in this study includes 5-FU and oxaliplatin. Arm B is 8 weeks longer than Arm A. Your doctor will discuss with you whether you will receive proton or photon radiation. If you receive proton radiation, it will be given in a building that is about a 5 minute drive from the main MD Anderson radiation clinic.
All participants will have had a routine upper gastrointestinal tract endoscopy and biopsy with endoscopic ultrasound examination before receiving treatment on this study. However, once you start on this study, the upper gastrointestinal tract endoscopy will be repeated before the 2nd cycle of induction chemotherapy Arm B (if needed), before chemoradiation, and before surgery. This procedure involves examination of the esophagus, stomach, and duodenum by a flexible tube. Biopsies will be taken as necessary.
Arm A:
If you are assigned to Arm A, you will receive treatment with 5-FU over 24 hours for 5 days each week for 5 weeks. It will be given as an infusion into a vein using a portable pump. This will start on Day 1 (Monday) and will continue until Day 5 (Friday) of each radiotherapy week for 5 weeks. You will need to carry this pump with you for about 96 hours. The pump is about the size of a personal compact disc player. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Day 1. This will be repeated on Days 8, 15, 22, and 29. During this time you will receive radiation therapy every weekday for 5 weeks.
If the cancer gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Each week while you are receiving chemoradiotherapy, around 1 tablespoon of blood will be drawn for routine tests. Between 5-6 weeks after the completion of chemoradiotherapy, the stage of the cancer will be evaluated. This includes drawing blood (about 1 tablespoon) for routine tests, an Electrocardiography (ECG), a Physical Fitness Testing (PFT), a computed tomography (CT) of the abdomen and chest (when necessary), a Positron emission tomography (PET) or PET/CT scan, and an upper GI endoscopy with biopsies and checking the status of your abdominal disease (if necessary).
When the evaluation of the status of your disease is complete, surgical removal of the primary tumor and lymph nodes will be attempted. All participants with no spreading disease, who are physically able to have surgery and have disease that is judged to be removable will be eligible for surgery. The tube (J-tube) will be left in your body for at least 8 weeks after the surgery to supplement your nutrition.
Arm B:
If you are assigned to Arm B, you will receive a starting (induction) course of chemotherapy before radiation therapy ever starts. You will receive 5-FU over 48 hours as an infusion into a vein using a portable pump. This will start on Day 1 and will continue over 48 hours. This will be repeated on Day 15 for another 48 hours. You will need to carry this pump with you at all times from Days 1-2 and Days 15-16. The pump is about the size of a personal compact disc player. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Days 1 and 15.
One cycle is equal to 28 days, which includes 2 doses of 5-FU and oxaliplatin given on Day 1 and Day 15. Treatment is always followed by 12 days of recovery. You will receive a maximum of 2 cycles (4 doses of 5-FU and oxaliplatin).
After the first and second cycles, you will be given a full physical exam, upper GI x-rays if necessary, about 1 tablespoon of blood will be drawn for routine blood tests, and if needed, a CT scan of the abdomen and chest will be performed. You will have a PET scan or PET CT scan and upper GI endoscopy with biopsy (if needed) before the start of Cycle 2 and after the end of Cycle 2. If the disease has not gotten worse after the 1st cycle of induction chemotherapy, you will receive the 2nd cycle. An upper gastrointestinal tract endoscopy and biopsy will be performed. If the disease gets worse at any stage, you will go straight to chemoradiotherapy. If the disease starts to spread, you will be taken off study and your doctor will discuss other treatment options with you.
You will begin to receive chemoradiotherapy no more than 12 days after you complete the last dose of induction chemotherapy. You will receive treatment with 5-FU over 24 hours for 5 days each week for 5 weeks. It will be given as an infusion into a vein using a portable pump. This will start on Day 1 (Monday) and will continue until Day 5 (Friday) of each radiotherapy week for 5 weeks. You will need to carry this pump with you at all times for about 96 hours. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Day 1. This will be repeated on Days 8, 15, 22, and 29. During this time you will receive radiation therapy every weekday for 5 weeks.
If the cancer gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Each week while you are receiving chemoradiotherapy, around 1 tablespoon of blood will be drawn for routine tests. Between 5-6 weeks after the completion of chemoradiotherapy, the stage of the cancer will be evaluated. This includes drawing blood (about 1 tablespoon) for routine tests, an ECG, a PFT, a CT of the abdomen and chest (when necessary), a PET Scan or PET CT Scan, and an upper GI endoscopy with biopsies and checking the status of your abdominal disease (if necessary).
When the evaluation of the status of your disease is complete, surgical removal of the primary tumor and lymph nodes will be attempted. All participants with no spreading disease, who are physically able to have surgery and have disease that is judged to be removable will be eligible for surgery. The a tube (J-tube) will be left in your body for at least 8 weeks after the surgery to supplement your nutrition.
Arms A and B:
You will be asked to fill out side effect sheets throughout your participation in this research study. You will be asked questions regarding nausea, hair loss, fatigue, meals, and other questions regarding your daily activities. You will be asked to keep a daily calendar while receiving therapy of any type.
You will be asked to come for follow-up visits at MD Anderson at 3, 6, 9, and 12 months after surgery and then every 6 months for 2 years, and then once a year for 2 years. At these visits, you will have a full physical exam, and about 1 tablespoon of blood drawn for routine tests and a CEA test (carcinoembryonic antigen - a protein made by cancer and normal cells) if your CEA level was high in the past. You will also have a PET scan, PET CT scan, or CT of the chest and abdomen. You will have an upper GI endoscopy with biopsies 3 months after surgery and at other follow-up visits if needed. You may have a CT of the chest and abdomen at the 3 month visit if needed.
This is an investigational study. Oxaliplatin is an investigational drug and is not approved in the US for use in the treatment of esophageal and gastroesophageal cancer. The combination of these 2 drugs (oxaliplatin + 5-FU) is investigational. All procedures are standard of care. A total of up to 126 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Esophageal Cancer, Gastroesophageal Cancer
- Being tested
- 5-Fluorouracil, Oxaliplatin, Radiation Therapy, Surgery
- Keywords
- Esophageal Cancer, Gastroesophageal Cancer, Gastroesophageal Junction, Radiation Therapy, 5-Fluorouracil, 5-FU, Adrucil, Efudex, Oxaliplatin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FluorouracilDrug
Also called 5-FU, Adrucil, Efudex
Arm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks.
Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15.
OxaliplatinDrug
Also called Eloxatin
Arm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks
Arm B: 100 mg/m^2 IV on Day 1 and 15
Radiation TherapyRadiation
Also called RT, XRT
Radiation treatment every weekday for 5 weeks.
SurgeryProcedure or surgery
Surgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Chemo with Radiation Treatment | Experimental | For 5 weeks, Chemo of 5-FU 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery. Receives: Drug: 5-Fluorouracil; Drug: Oxaliplatin; Radiation: Radiation Therapy; Procedure: Surgery |
| Arm B: Pre-Op Chemo + Chemo with Radiation Treatment | Experimental | Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A) Receives: Drug: 5-Fluorouracil; Drug: Oxaliplatin; Radiation: Radiation Therapy; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.
Measured: Surgery post chemotherapy (approximately 10-11 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startApr 2005
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Jaffer Ajani, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525915
- Sponsor's protocol ID
- 2004-0703
- Status last verified
- Jan 2015
- First submitted
- 4 Sep 2007
- Last updated
- 9 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shimodaira Y, Slack RS, Harada K, Chen HC, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Blum MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Mares J, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Influence of induction chemotherapy in trimodality therapy-eligible oesophageal cancer patients: secondary analysis of a randomised trial. Br J Cancer. 2018 Feb 6;118(3):331-337. doi: 10.1038/bjc.2017.423. Epub 2017 Dec 12.
PubMed 29235564Harada K, Wang X, Shimodaira Y, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Lopez A, Blum Murphy MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Early Metabolic Change after Induction Chemotherapy Predicts Histologic Response and Prognosis in Patients with Esophageal Cancer: Secondary Analysis of a Randomized Trial. Target Oncol. 2018 Feb;13(1):99-106. doi: 10.1007/s11523-017-0540-3.
PubMed 29218623Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.
PubMed 23975663
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Oxaliplatin-Based Phase II Randomized Study of Induction Chemotherapy Followed by Preoperative Chemoradiotherapy or Preoperative Chemoradiotherapy in Patients With Resectable Esophageal or Gastroesophageal Carcinoma
- ClinicalTrials.gov ID
- NCT00525915
- Acronym / sponsor ID
- 2004-0703
- Conditions
- Esophageal Cancer, Gastroesophageal Cancer
- Keywords
- Esophageal Cancer, Gastroesophageal Cancer, Gastroesophageal Junction, Radiation Therapy, 5-Fluorouracil, 5-FU, Adrucil, Efudex
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Posted 9 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if a combination of the investigational drug oxaliplatin with 5-Fluorouracil (5-FU) (given at the same time as radiation therapy) is as effective as a combination of these two drugs given before and during radiation therapy in the treatment of esophageal or gastroesophageal cancers. The safety of these combinations of therapy will also be compared.
Objectives:
Primary objective:
Compare the Pathologic Complete Response rate and % of patients with <50% residual cancer in the resected surgical specimen between Arms A and B.
Secondary objectives:
- Compare 1-year and 3-year survival rates, median survival time, R0 resection rates, safety, and local plus systemic relapse rates between Arms A and B
- Perform exploratory correlative studies on blood, adjacent normal and cancer tissue to assess predictive markers of response and outcome.
- Evaluate the joint effects, including possible interactive effects, of proton-versus-photon therapy and treatment arm on overall survival, R0 resection rates, safety, and local plus systemic relapse rates.
Detailed description
Oxaliplatin and 5-FU are chemotherapy drugs that are commonly used to treat certain kinds of cancers. 5-FU is designed to prevent cells from making DNA that is necessary for cell growth. This disrupts the growth of the cancer cells, which causes the cancer cells to start to die. Oxaliplatin is designed to damage DNA that is already formed.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in the first group (Arm A) will receive chemotherapy with radiation treatment. Participants in the second group (Arm B) will receive chemotherapy first then chemotherapy with radiation treatment. The chemotherapy that will be used in this study includes 5-FU and oxaliplatin. Arm B is 8 weeks longer than Arm A. Your doctor will discuss with you whether you will receive proton or photon radiation. If you receive proton radiation, it will be given in a building that is about a 5 minute drive from the main MD Anderson radiation clinic.
All participants will have had a routine upper gastrointestinal tract endoscopy and biopsy with endoscopic ultrasound examination before receiving treatment on this study. However, once you start on this study, the upper gastrointestinal tract endoscopy will be repeated before the 2nd cycle of induction chemotherapy Arm B (if needed), before chemoradiation, and before surgery. This procedure involves examination of the esophagus, stomach, and duodenum by a flexible tube. Biopsies will be taken as necessary.
Arm A:
If you are assigned to Arm A, you will receive treatment with 5-FU over 24 hours for 5 days each week for 5 weeks. It will be given as an infusion into a vein using a portable pump. This will start on Day 1 (Monday) and will continue until Day 5 (Friday) of each radiotherapy week for 5 weeks. You will need to carry this pump with you for about 96 hours. The pump is about the size of a personal compact disc player. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Day 1. This will be repeated on Days 8, 15, 22, and 29. During this time you will receive radiation therapy every weekday for 5 weeks.
If the cancer gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Each week while you are receiving chemoradiotherapy, around 1 tablespoon of blood will be drawn for routine tests. Between 5-6 weeks after the completion of chemoradiotherapy, the stage of the cancer will be evaluated. This includes drawing blood (about 1 tablespoon) for routine tests, an Electrocardiography (ECG), a Physical Fitness Testing (PFT), a computed tomography (CT) of the abdomen and chest (when necessary), a Positron emission tomography (PET) or PET/CT scan, and an upper GI endoscopy with biopsies and checking the status of your abdominal disease (if necessary).
When the evaluation of the status of your disease is complete, surgical removal of the primary tumor and lymph nodes will be attempted. All participants with no spreading disease, who are physically able to have surgery and have disease that is judged to be removable will be eligible for surgery. The tube (J-tube) will be left in your body for at least 8 weeks after the surgery to supplement your nutrition.
Arm B:
If you are assigned to Arm B, you will receive a starting (induction) course of chemotherapy before radiation therapy ever starts. You will receive 5-FU over 48 hours as an infusion into a vein using a portable pump. This will start on Day 1 and will continue over 48 hours. This will be repeated on Day 15 for another 48 hours. You will need to carry this pump with you at all times from Days 1-2 and Days 15-16. The pump is about the size of a personal compact disc player. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Days 1 and 15.
One cycle is equal to 28 days, which includes 2 doses of 5-FU and oxaliplatin given on Day 1 and Day 15. Treatment is always followed by 12 days of recovery. You will receive a maximum of 2 cycles (4 doses of 5-FU and oxaliplatin).
After the first and second cycles, you will be given a full physical exam, upper GI x-rays if necessary, about 1 tablespoon of blood will be drawn for routine blood tests, and if needed, a CT scan of the abdomen and chest will be performed. You will have a PET scan or PET CT scan and upper GI endoscopy with biopsy (if needed) before the start of Cycle 2 and after the end of Cycle 2. If the disease has not gotten worse after the 1st cycle of induction chemotherapy, you will receive the 2nd cycle. An upper gastrointestinal tract endoscopy and biopsy will be performed. If the disease gets worse at any stage, you will go straight to chemoradiotherapy. If the disease starts to spread, you will be taken off study and your doctor will discuss other treatment options with you.
You will begin to receive chemoradiotherapy no more than 12 days after you complete the last dose of induction chemotherapy. You will receive treatment with 5-FU over 24 hours for 5 days each week for 5 weeks. It will be given as an infusion into a vein using a portable pump. This will start on Day 1 (Monday) and will continue until Day 5 (Friday) of each radiotherapy week for 5 weeks. You will need to carry this pump with you at all times for about 96 hours. You will also receive oxaliplatin as an infusion into a vein over 2 hours on Day 1. This will be repeated on Days 8, 15, 22, and 29. During this time you will receive radiation therapy every weekday for 5 weeks.
If the cancer gets worse or you experience intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Each week while you are receiving chemoradiotherapy, around 1 tablespoon of blood will be drawn for routine tests. Between 5-6 weeks after the completion of chemoradiotherapy, the stage of the cancer will be evaluated. This includes drawing blood (about 1 tablespoon) for routine tests, an ECG, a PFT, a CT of the abdomen and chest (when necessary), a PET Scan or PET CT Scan, and an upper GI endoscopy with biopsies and checking the status of your abdominal disease (if necessary).
When the evaluation of the status of your disease is complete, surgical removal of the primary tumor and lymph nodes will be attempted. All participants with no spreading disease, who are physically able to have surgery and have disease that is judged to be removable will be eligible for surgery. The a tube (J-tube) will be left in your body for at least 8 weeks after the surgery to supplement your nutrition.
Arms A and B:
You will be asked to fill out side effect sheets throughout your participation in this research study. You will be asked questions regarding nausea, hair loss, fatigue, meals, and other questions regarding your daily activities. You will be asked to keep a daily calendar while receiving therapy of any type.
You will be asked to come for follow-up visits at MD Anderson at 3, 6, 9, and 12 months after surgery and then every 6 months for 2 years, and then once a year for 2 years. At these visits, you will have a full physical exam, and about 1 tablespoon of blood drawn for routine tests and a CEA test (carcinoembryonic antigen - a protein made by cancer and normal cells) if your CEA level was high in the past. You will also have a PET scan, PET CT scan, or CT of the chest and abdomen. You will have an upper GI endoscopy with biopsies 3 months after surgery and at other follow-up visits if needed. You may have a CT of the chest and abdomen at the 3 month visit if needed.
This is an investigational study. Oxaliplatin is an investigational drug and is not approved in the US for use in the treatment of esophageal and gastroesophageal cancer. The combination of these 2 drugs (oxaliplatin + 5-FU) is investigational. All procedures are standard of care. A total of up to 126 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Chemo with Radiation Treatment | Experimental | Drug: 5-Fluorouracil, Drug: Oxaliplatin, Radiation: Radiation Therapy, Procedure: SurgeryFor 5 weeks, Chemo of 5-FU 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery. |
| Arm B: Pre-Op Chemo + Chemo with Radiation Treatment | Experimental | Drug: 5-Fluorouracil, Drug: Oxaliplatin, Radiation: Radiation Therapy, Procedure: SurgeryPre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A) |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Local regional carcinoma of the thoracic esophagus (squamous cell or adeno) or gastroesophageal junction.
- Patients with T1N1, and T2-3 with any N (M1a only) will be eligible.
- Normal liver (serum glutamic-pyruvic transaminase (SGPT) < 56µL, Total Bilirubin <1.5 mg/dL), kidney (Creatinine <1.75 mg/dL), and bone marrow functions (AGN >1,500µL, platelet count >100,000/µL).
- Performance status 0 or 1.
- Signed informed consent by the investigator or their designee and patient.
Key exclusion criteria (4 listed)
- Patients with T1N0, T4, or M1b cancer will be excluded
- Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension, or active psychiatric condition that prevents consistent participation and compliance).
- More than grade 1 neuropathy
- Unable to comprehend the requirements of the study or comply with it.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-FluorouracilAlso: 5-FU, Adrucil, EfudexArm A = 250 mg/m^2 IV over 24 hours for 5 days weekly for 5 weeks. Arm B = 2.2 mg/m^2 IV over 48 hours on days 1 and 15. | Drug | Arm A: Chemo with Radiation Treatment, Arm B: Pre-Op Chemo + Chemo with Radiation Treatment |
| OxaliplatinAlso: EloxatinArm A: 40 mg/m^2 IV daily over 2 hours for 5 weeks Arm B: 100 mg/m^2 IV on Day 1 and 15 | Drug | Arm A: Chemo with Radiation Treatment, Arm B: Pre-Op Chemo + Chemo with Radiation Treatment |
| Radiation TherapyAlso: RT, XRTRadiation treatment every weekday for 5 weeks. | Radiation | Arm A: Chemo with Radiation Treatment, Arm B: Pre-Op Chemo + Chemo with Radiation Treatment |
| SurgerySurgical removal of the primary tumor and lymph nodes following completion of disease status evaluation post chemotherapy and radiation treatments. | Procedure or surgery | Arm A: Chemo with Radiation Treatment, Arm B: Pre-Op Chemo + Chemo with Radiation Treatment |
Primary outcome
Pathologic Complete Response Rate
Time frame: Surgery post chemotherapy (approximately 10-11 weeks)
Pathologic Complete Response rate: percentage of participants with response reported as Pathologic complete response (pathCR) following surgery. Once surgery performed, response to therapy judged in surgical specimen with three possible categories reported: 1) Pathologic complete response (no residual cancer in the specimen); 2) <50% of residual cells in the surgical specimen; or 3) >50% of cells in the surgical specimen. Upon recovery from chemoradiation (Chemo), surgery follows approximately 5-6 weeks later with response assessment. Arm A schedule consists of 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. Arm B schedule consist of 8 weeks of Chemo, followed by 6 weeks of Chemo +XRT, followed by 5-6 weeks of rest, followed by surgery. In particular, Arm B is 8 weeks longer than Arm A.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29235564Shimodaira Y, Slack RS, Harada K, Chen HC, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Blum MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Mares J, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Influence of induction chemotherapy in trimodality therapy-eligible oesophageal cancer patients: secondary analysis of a randomised trial. Br J Cancer. 2018 Feb 6;118(3):331-337. doi: 10.1038/bjc.2017.423. Epub 2017 Dec 12.
- Derived from this study: PubMed 29218623Harada K, Wang X, Shimodaira Y, Sagebiel T, Bhutani MS, Lee JH, Weston B, Elimova E, Lin Q, Amlashi FG, Mizrak Kaya D, Lopez A, Blum Murphy MA, Roth JA, Swisher SG, Skinner HD, Hofstetter WL, Rogers JE, Thomas I, Maru DM, Komaki R, Walsh G, Ajani JA. Early Metabolic Change after Induction Chemotherapy Predicts Histologic Response and Prognosis in Patients with Esophageal Cancer: Secondary Analysis of a Randomized Trial. Target Oncol. 2018 Feb;13(1):99-106. doi: 10.1007/s11523-017-0540-3.
- Derived from this study: PubMed 23975663Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.
- UT MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaffer Ajani, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-Fluorouracil, Oxaliplatin and Radiation Therapy in people with Esophageal Cancer and Gastroesophageal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response Rate (time frame: Surgery post chemotherapy (approximately 10-11 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525915, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.