Rectal CancerPhase 1/2NCT00503932
Proton Therapy With Capecitabine for Rectal Cancer
A Phase 1/2 study testing Proton Therapy and Capecitabine in people with Rectal Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I portion of this trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Proton Therapy and Capecitabine
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Apr 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have clinical stage T4 or recurrent adenocarcinoma of the rectum. Patients will be regarded as having clinical stage T4 if there is evidence of invasion of other structures on one or more of the following: endorectal ultrasound, pelvic CT, and physical examination, including pelvic examination
- Histology must be confirmed with review by the Department of Pathology at UT MD Anderson Cancer Center.
- All patients must have no distant metastatic disease in the liver, peritoneum, lungs, or paraaortic lymph nodes.
- Patients must have a performance status (Karnofsky scale) of 70% or greater, and be able to tolerate the proposed radiation and chemotherapy regimen.
- There are no age restrictions for this protocol.
- Patients must have WBC > 4000 cells/mm^3, platelets > 150,000/mm^3, total serum bilirubin < 2 mg/dl, BUN <30 mg/dl, creatinine < 1.5 mg/dl and creatinine clearance > 50cc/min (estimated as calculated with Cockcroft-Gault equation).
- Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary. Patients must sign a study-specific consent form, which is attached to this protocol.
Who cannot join
- Prior radiotherapy to the pelvis.
- Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman / men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration. Sexually active males must practice contraception during the study.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrythmia or tachycardia (heart rate > 100 beats/minute), poorly controlled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg) or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
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- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or capecitabine.
- Patients on coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) coumadin is allowed.
- Aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox must be stopped during this study.
- Patients </= 18 years.
About this study
Official title: A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer
The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I portion of this trial.
The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD.
Read more
Secondary Objectives:
- To evaluate local tumor response in patients treated with the above regimen.
- To evaluate the relapse-free and overall survival in patients treated with the above regimen.
- To evaluate proton dosimetry in patients receiving this treatment.
- To evaluate quality of life in patients receiving this therapy.
Read the detailed description
Proton beams can be used to deliver a high dose of radiation to the treatment area while sparing surrounding normal tissues. Capecitabine is a drug that interferes with the growth of cancer cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Urine will be collected for routine tests. Chest x-rays and computed tomography (CT) scans of the abdomen (stomach area) and pelvis will be done. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all). You will take the chemotherapy drug, capecitabine, by mouth 2 times a day, at morning and night, on each of the days that you receive radiation therapy. These pills will not be taken on Saturday or Sunday. These pills should be taken within 30 minutes of eating and with a full glass of water.
During the study, every week you will have a physical exam and blood (about 2 teaspoons) will be drawn to check for side effects from chemotherapy and radiation therapy. You will be asked about any side effects you are experiencing.
You will be evaluated by a surgeon 4-6 weeks after the completion of treatment. Those with tumors that can be surgically removed will have surgery to remove the tumor 6-8 weeks after completion of treatment, as they would for the standard of care for their disease.
You will be taken off study if the disease gets worse or intolerable side effects occur.
Two (2) weeks after completing radiation therapy, you will have a follow-up visit. At this visit, you will have a physical exam. Blood (about 2 teaspoons) will be collected for routine tests. You will be asked about any side effects you are experiencing. Six (6) weeks after completing radiation therapy, you will have a follow-up visit. At this visit, you will have a physical exam, chest x-ray, and CT scan of your abdomen and pelvis. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will be asked about any side effects you are experiencing.
After finishing treatment, you will have a follow-up visit every 3 months for the first 2 years, and every 6 months after that. At each visit, you will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and CT scan of the abdomen and pelvis. You will be asked about any side effects you are experiencing.
One (1) year after you finish treatment, you will also have a colonoscopy or sigmoidoscopy. You will receive a separate consent for these procedures.
After participation in the study is over, you will have follow-up evaluation as needed for standard of care.
This is an investigational study. Capecitabine is FDA approved for treating colon cancer after surgery, and for treating metastatic colorectal cancer. The use of capecitabine with proton beam therapy in this study is investigational. About 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Rectal Cancer
- Being tested
- Proton Therapy, Capecitabine
- Keywords
- Rectal Cancer, Capecitabine, Proton Therapy, Adenocarcinoma of the rectum, Gastrointestinal, Proton Radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton TherapyProcedure or surgery
Also called Proton-based radiotherapy, radiotherapy, Proton-RT, RT
Radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all).
CapecitabineDrug
Also called Xeloda
825 mg/m^2 by mouth (PO) twice daily on days receive radiation.
| Study group | Role | What they receive |
|---|---|---|
| Proton Therapy + Capecitabine | Experimental | Capecitabine 825 mg/m^2 by mouth twice daily on Proton Therapy (radiation) days. Receives: Procedure: Proton Therapy; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
MTD of a fixed dose of capecitabine (825 mg/m²) and 3 escalating doses of proton radiotherapy (5400, 5940, 6300 cobalt centiGray equivalent) as measured by dose-limiting toxicities using the continual reassessment method (CRM).
Measured: 2 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: No participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prajnan Das, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503932
- Sponsor's protocol ID
- 2005-0657
- Status last verified
- Mar 2012
- First submitted
- 17 Jul 2007
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT00503932
- Acronym / sponsor ID
- 2005-0657
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, Capecitabine, Proton Therapy, Adenocarcinoma of the rectum, Gastrointestinal, Proton Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participant enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer. The maximum tolerated dose (MTD) will be determined in the Phase I portion of this trial.
The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD.
Secondary Objectives:
- To evaluate local tumor response in patients treated with the above regimen.
- To evaluate the relapse-free and overall survival in patients treated with the above regimen.
- To evaluate proton dosimetry in patients receiving this treatment.
- To evaluate quality of life in patients receiving this therapy.
Detailed description
Proton beams can be used to deliver a high dose of radiation to the treatment area while sparing surrounding normal tissues. Capecitabine is a drug that interferes with the growth of cancer cells.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete physical exam. Blood (about 2 tablespoons) will be drawn for routine tests. Urine will be collected for routine tests. Chest x-rays and computed tomography (CT) scans of the abdomen (stomach area) and pelvis will be done. Women who are able to have children must have a negative blood or urine pregnancy test.
If you are found to be eligible to take part in this study, you will receive radiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all). You will take the chemotherapy drug, capecitabine, by mouth 2 times a day, at morning and night, on each of the days that you receive radiation therapy. These pills will not be taken on Saturday or Sunday. These pills should be taken within 30 minutes of eating and with a full glass of water.
During the study, every week you will have a physical exam and blood (about 2 teaspoons) will be drawn to check for side effects from chemotherapy and radiation therapy. You will be asked about any side effects you are experiencing.
You will be evaluated by a surgeon 4-6 weeks after the completion of treatment. Those with tumors that can be surgically removed will have surgery to remove the tumor 6-8 weeks after completion of treatment, as they would for the standard of care for their disease.
You will be taken off study if the disease gets worse or intolerable side effects occur.
Two (2) weeks after completing radiation therapy, you will have a follow-up visit. At this visit, you will have a physical exam. Blood (about 2 teaspoons) will be collected for routine tests. You will be asked about any side effects you are experiencing. Six (6) weeks after completing radiation therapy, you will have a follow-up visit. At this visit, you will have a physical exam, chest x-ray, and CT scan of your abdomen and pelvis. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will be asked about any side effects you are experiencing.
After finishing treatment, you will have a follow-up visit every 3 months for the first 2 years, and every 6 months after that. At each visit, you will have a physical exam. Blood (about 2 teaspoons) and urine will be collected for routine tests. You will have a chest x-ray and CT scan of the abdomen and pelvis. You will be asked about any side effects you are experiencing.
One (1) year after you finish treatment, you will also have a colonoscopy or sigmoidoscopy. You will receive a separate consent for these procedures.
After participation in the study is over, you will have follow-up evaluation as needed for standard of care.
This is an investigational study. Capecitabine is FDA approved for treating colon cancer after surgery, and for treating metastatic colorectal cancer. The use of capecitabine with proton beam therapy in this study is investigational. About 50 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Therapy + Capecitabine | Experimental | Procedure: Proton Therapy, Drug: CapecitabineCapecitabine 825 mg/m^2 by mouth twice daily on Proton Therapy (radiation) days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients must have clinical stage T4 or recurrent adenocarcinoma of the rectum. Patients will be regarded as having clinical stage T4 if there is evidence of invasion of other structures on one or more of the following: endorectal ultrasound, pelvic CT, and physical examination, including pelvic examination
- Histology must be confirmed with review by the Department of Pathology at UT MD Anderson Cancer Center.
- All patients must have no distant metastatic disease in the liver, peritoneum, lungs, or paraaortic lymph nodes.
- Patients must have a performance status (Karnofsky scale) of 70% or greater, and be able to tolerate the proposed radiation and chemotherapy regimen.
- There are no age restrictions for this protocol.
Key exclusion criteria (10 listed)
- Prior radiotherapy to the pelvis.
- Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman / men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration. Sexually active males must practice contraception during the study.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrythmia or tachycardia (heart rate > 100 beats/minute), poorly controlled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg) or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded.
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
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 |
|---|---|---|
| Proton TherapyAlso: Proton-based radiotherapy, radiotherapy, Proton-RT, RTRadiation therapy 1 time a day, for 5 days in a row (Monday-Friday) for 6 -7 weeks (30-35 treatments in all). | Procedure or surgery | Proton Therapy + Capecitabine |
| CapecitabineAlso: Xeloda825 mg/m^2 by mouth (PO) twice daily on days receive radiation. | Drug | Proton Therapy + Capecitabine |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 2 weeks after completion of radiotherapy
MTD of a fixed dose of capecitabine (825 mg/m²) and 3 escalating doses of proton radiotherapy (5400, 5940, 6300 cobalt centiGray equivalent) as measured by dose-limiting toxicities using the continual reassessment method (CRM).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
- MD Anderson Cancer Center 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.
Prajnan Das, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proton Therapy and Capecitabine in people with Rectal Cancer, run by M.D. Anderson Cancer Center.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum Tolerated Dose (MTD) (time frame: 2 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2012.