Gastrointestinal NeoplasmPhase 3NCT00052962
Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis
A Phase 3 study testing Cytoreductive surgery and Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP) in people with Gastrointestinal Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will determine which of the two following treatment regimens provides greater benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread throughout the abdomen): Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose of chemotherapy 7 to 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm
- What is being tested?
- Cytoreductive surgery and Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Sep 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have histologically or cytologically proven peritoneal carcinomatosis from low-grade mucinous adenocarcinoma of the gastrointestinal tract. Patients with no tissue for examination may undergo percutaneous needle aspiration under computed tomography (CT) or ultrasound guidance as clinically indicated or a laparotomy with biopsy if a tumor grade cannot be determined on other available material.
- Radiologic workup must demonstrate that there is no imageable disease outside of the peritoneal cavity.
- Radiologic workup or prior abdominal exploration must show abnormalities consistent with disease which can be debulked to a residual size of less than 1 cm in diameter per tumor deposit in the judgement of the investigators.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 on study entry and on the day prior to planned treatment.
- Patients must have a minimum expected duration of survival of greater than 16 weeks.
- Patients must have recovered from any severe toxicity from all prior chemotherapy, immunotherapy or radiotherapy except as outlined in appendix 1 of the protocol and be at least 30 days past the date of their last treatment.
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- Patients must have a serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal and a total serum bilirubin of less than 3 times the upper limit of normal, both of which define the upper limit of grade 2 treatment related toxicities..
- Patients must have a absolute neutrophil count (ANC) greater than 1,500/microliter.
- Patients must be age greater than or equal to 18 years.
Who cannot join
- Patients will be excluded if they have concomitant medical problems that would place them at unacceptable risk for a major surgical procedure.
- Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g. age greater than 65, and a history of hypertension, first degree relative with atherosclerotic coronary artery evaluation and will not be eligible if they demonstrate significant irreversible ischemia on a stress thallium study or an ejection fraction of less than 40%.
- Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their forced expiratory volume 1 (FEV1) is less than 1.2 liters or their maximum voluntary ventilation is less than 50% of expected.
- Patients who have a neurological toxicity of Grade 3 or greater will be excluded because of the potential neurotoxicity associated with platinum and paclitaxel therapy.
- Patients will be ineligible if they have a serum creatinine of greater than 1.5 mg/dL unless the measured creatinine clearance is greater than 60mL/min/1.73m^2.
- Patients will be ineligible if platelets are less than 75, 000/mm^3.
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- Patients who have failed previous intraperitoneal chemotherapy will be ineligible.
- Pregnant women or women who are breast-feeding will be ineligible.
- Patients less than 30 kg will be ineligible.
- Patients who have undergone two or more operative procedures to debulk disease, have received 2 or more regimens of systemic chemotherapy, or any previous continuous hyperthermic peritoneal perfusion (CHPP) therapy will be excluded from study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: A Prospective Random Assignment Trial to Study Operative Debulking and Systemic Chemotherapy With or Without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects With Peritoneal Carcinomatosis From Low Grade Gastrointestinal Adenocarcinoma
This study will determine which of the two following treatment regimens provides greater benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread throughout the abdomen):
- Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose of chemotherapy 7 to 12 days after surgery, followed 3 weeks later by 4 months of chemotherapy; or
- Surgical removal of tumors followed by 4 months of chemotherapy, starting 1 month after surgery.
Read more
Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests; chest X-ray and computed tomography (CT) scans; review of pathology slides; electrocardiogram (EKG), bone scan, and brain magnetic resonance imaging (MRI), as needed; and laparotomy. Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the amount and location of tumors in the abdominal cavity. Patients whose surgery reveals that the tumors cannot be removed are taken off study. Those eligible for the study have their tumors removed during this screening laparotomy as part of the study procedure, as follows:
All participants undergo laparotomy and removal of as much tumor as possible, as described above. Patients are then randomly assigned to one of two treatment groups:
- Group 1 - During laparotomy, after tumor removal, patients receive continuous hyperthermic peritoneal perfusion (CHPP) with the anti-cancer drug cisplatin. For CHPP, the cisplatin solution is heated and delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter. At the close of surgery, a small catheter, called a Tenckhoff catheter, is left in the abdomen and brought out through the skin. Between days 7 and 12 after surgery, one dose of fluorouracil and paclitaxel chemotherapy is delivered through this catheter. The catheter is removed following complete recovery from surgery and the patient is discharged from the hospital. Four to 6 weeks after the surgery, patients have CT scans of the chest, pelvis, and abdomen, and then begin intravenous (IV, through a vein) chemotherapy with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin. The chemotherapy is given in 4-week courses as follows: oxaliplatin on day 1, infused over 2 hours through a vein in the arm or neck; leucovorin on days 1 and 2, infused over 2 hours, followed by 5-fluorouracil over 22 hours; leucovorin and 5-FU repeated two weeks later on days 15 and 16. This regimen is repeated two weeks later. Between each week of chemotherapy is a week break. A course of chemotherapy consists of 28 days (two weeks of chemotherapy and two 1-week breaks). Patients may receive up to four courses (total of 16 weeks) unless their disease progresses or they cannot tolerate further doses. Doses of the chemotherapy can be reduced if the side effects are too severe.
- Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy, CT imaging, and IV chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin. They do not receive CHPP or chemotherapy into the abdomen.
All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of the intravenous (IV) chemotherapy. They return for a physical examination and CT scans every three months for the first year, every four months for the next two years, and then every six months for up to five years after treatment. They are also asked to complete quality of life questionnaires before and after surgery, at the completion of chemotherapy, and at every follow-up visit.
Read the detailed description
Patients with low-grade gastrointestinal adenocarcinoma and peritoneal carcinomatosis will undergo laparotomy and tumor debulking. Patients will be randomized at completion of tumor debulking to receive continuous hyperthermic peritoneal perfusion (HIPEC,formerly CHPP) with 250 mg/m^2 cisplatin and an intraperitoneal dwell of 5-fluorouracil 800 mg/m^2 and paclitaxel 125 mg/m^2 once between postoperative day 7 and 12. All patients will receive systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks starting 4 to 6 weeks after operation and continuing for four cycles. The major endpoint is time to intraperitoneal tumor progression and survival in patients stratified based on history of previous treatment with systemic chemotherapy (yes vs. no), history of prior debulking surgery; and ability to optimally vs. suboptimally debulk intraperitoneal tumor burden.
- Conditions
- Gastrointestinal Neoplasm
- Being tested
- Cytoreductive surgery, Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)
- Keywords
- Appendiceal Cancer, Regional Therapy, Carcinomatosis, Hyperthermia
- Medical subject headings
- Gastrointestinal Neoplasms, Appendiceal Neoplasms, Carcinoma, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgeryProcedure or surgery
Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.
Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}.
Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)Procedure or surgery
Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size.
Followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m^2 cisplatin. Post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluororacil (5-FU) 800 mg/m^2 and paclitaxel 125 mg/m^2.
Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Surgery + post op chemotherapy | Other | * Cytoreductive surgery - patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity, with cytoreductive surgery, or tumor debulking to reduce tumor size.
* Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}. Receives: Procedure: Cytoreductive surgery |
| Arm 2 Surgery + HIPEC | Other | Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP/HIPEC) + post op dwell + post op chemotherapy
* Cytoreductive surgery - patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity, with cytoreductive surgery, or tumor debulking to reduce tumor size.
* followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m^2 cisplatin
* post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
* post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}. Receives: Procedure: Cytoreductive surgery; Procedure: Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter.
Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans.
Measured: 2003-2008
Secondary outcomes (1)
Number of Participants With an Adverse Event
Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.
Measured: 2003-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJan 2003
- Primary completionSep 2008
- Study completionSep 2008
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 (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Marybeth Hughes, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052962
- Sponsor's protocol ID
- 030085
- Other IDs
- 03-C-0085
- Status last verified
- Nov 2012
- First submitted
- 26 Jan 2003
- Last updated
- 22 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000 Mar 25;355(9209):1041-7. doi: 10.1016/s0140-6736(00)02034-1.
PubMed 10744089
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Random Assignment Trial to Study Operative Debulking and Systemic Chemotherapy With or Without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects With Peritoneal Carcinomatosis From Low Grade Gastrointestinal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00052962
- Acronym / sponsor ID
- 030085
- Conditions
- Gastrointestinal Neoplasm
- Keywords
- Appendiceal Cancer, Regional Therapy, Carcinomatosis, Hyperthermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 19 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine which of the two following treatment regimens provides greater benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread throughout the abdomen):
- Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose of chemotherapy 7 to 12 days after surgery, followed 3 weeks later by 4 months of chemotherapy; or
- Surgical removal of tumors followed by 4 months of chemotherapy, starting 1 month after surgery.
Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests; chest X-ray and computed tomography (CT) scans; review of pathology slides; electrocardiogram (EKG), bone scan, and brain magnetic resonance imaging (MRI), as needed; and laparotomy. Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the amount and location of tumors in the abdominal cavity. Patients whose surgery reveals that the tumors cannot be removed are taken off study. Those eligible for the study have their tumors removed during this screening laparotomy as part of the study procedure, as follows:
All participants undergo laparotomy and removal of as much tumor as possible, as described above. Patients are then randomly assigned to one of two treatment groups:
- Group 1 - During laparotomy, after tumor removal, patients receive continuous hyperthermic peritoneal perfusion (CHPP) with the anti-cancer drug cisplatin. For CHPP, the cisplatin solution is heated and delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter. At the close of surgery, a small catheter, called a Tenckhoff catheter, is left in the abdomen and brought out through the skin. Between days 7 and 12 after surgery, one dose of fluorouracil and paclitaxel chemotherapy is delivered through this catheter. The catheter is removed following complete recovery from surgery and the patient is discharged from the hospital. Four to 6 weeks after the surgery, patients have CT scans of the chest, pelvis, and abdomen, and then begin intravenous (IV, through a vein) chemotherapy with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin. The chemotherapy is given in 4-week courses as follows: oxaliplatin on day 1, infused over 2 hours through a vein in the arm or neck; leucovorin on days 1 and 2, infused over 2 hours, followed by 5-fluorouracil over 22 hours; leucovorin and 5-FU repeated two weeks later on days 15 and 16. This regimen is repeated two weeks later. Between each week of chemotherapy is a week break. A course of chemotherapy consists of 28 days (two weeks of chemotherapy and two 1-week breaks). Patients may receive up to four courses (total of 16 weeks) unless their disease progresses or they cannot tolerate further doses. Doses of the chemotherapy can be reduced if the side effects are too severe.
- Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy, CT imaging, and IV chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin. They do not receive CHPP or chemotherapy into the abdomen.
All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of the intravenous (IV) chemotherapy. They return for a physical examination and CT scans every three months for the first year, every four months for the next two years, and then every six months for up to five years after treatment. They are also asked to complete quality of life questionnaires before and after surgery, at the completion of chemotherapy, and at every follow-up visit.
Detailed description
Patients with low-grade gastrointestinal adenocarcinoma and peritoneal carcinomatosis will undergo laparotomy and tumor debulking. Patients will be randomized at completion of tumor debulking to receive continuous hyperthermic peritoneal perfusion (HIPEC,formerly CHPP) with 250 mg/m^2 cisplatin and an intraperitoneal dwell of 5-fluorouracil 800 mg/m^2 and paclitaxel 125 mg/m^2 once between postoperative day 7 and 12. All patients will receive systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks starting 4 to 6 weeks after operation and continuing for four cycles. The major endpoint is time to intraperitoneal tumor progression and survival in patients stratified based on history of previous treatment with systemic chemotherapy (yes vs. no), history of prior debulking surgery; and ability to optimally vs. suboptimally debulk intraperitoneal tumor burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Surgery + post op chemotherapy | Other | Procedure: Cytoreductive surgery* Cytoreductive surgery - patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity, with cytoreductive surgery, or tumor debulking to reduce tumor size. * Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}. |
| Arm 2 Surgery + HIPEC | Other | Procedure: Cytoreductive surgery, Procedure: Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP/HIPEC) + post op dwell + post op chemotherapy * Cytoreductive surgery - patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity, with cytoreductive surgery, or tumor debulking to reduce tumor size. * followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m^2 cisplatin * post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2 * post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (10 listed)
- Patients will be excluded if they have concomitant medical problems that would place them at unacceptable risk for a major surgical procedure.
- Patients who have a neurological toxicity of Grade 3 or greater will be excluded because of the potential neurotoxicity associated with platinum and paclitaxel therapy.
- Patients will be ineligible if they have a serum creatinine of greater than 1.5 mg/dL unless the measured creatinine clearance is greater than 60mL/min/1.73m^2.
- Patients will be ineligible if platelets are less than 75, 000/mm^3.
- Patients who have failed previous intraperitoneal chemotherapy will be ineligible.
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 |
|---|---|---|
| Cytoreductive surgeryPatients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size. Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}. | Procedure or surgery | Arm 1 Surgery + post op chemotherapy, Arm 2 Surgery + HIPEC |
| Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)Patients will undergo a laparotomy, surgical incision in the abdomen to assess the peritoneal cavity with cytoreductive surgery or tumor debulking, to reduce tumor size. Followed by continuous hyperthermic peritoneal perfusion (HIPEC) with 250 mg/m^2 cisplatin. Post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluororacil (5-FU) 800 mg/m^2 and paclitaxel 125 mg/m^2. Drug: Post operative chemotherapy: systemic oxaliplatin 85 mg/m^2 on day 1 only, leucovorin 200 mg/M^2/day on day 1, 2, 15, and 16, and infusional 5-flurouracil (5-FU) 800 mg/m^2 on day 8, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles { 16 weeks total}. | Procedure or surgery | Arm 2 Surgery + HIPEC |
Primary outcome
Progression Free Survival
Time frame: 2003-2008
CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter. Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans.
1 secondary outcome
Number of Participants With an Adverse Event
Time frame: 2003-2008
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10744089Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000 Mar 25;355(9209):1041-7. doi: 10.1016/s0140-6736(00)02034-1.
- NIH Clinical Center Detailed Web PageLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytoreductive surgery and Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP) in people with Gastrointestinal Neoplasm, run by National Cancer Institute (NCI) 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 9 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: finished, as of the sponsor's last update on 22 Nov 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 19 Nov 2012). 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?
Progression Free Survival (time frame: 2003-2008). 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 NCT00052962, which also lists 1 linked publication.
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 Nov 2012.