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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00052962 |
Purpose
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):
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 CT scans; review of pathology slides; EKG, bone scan, and brain 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:
All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of the 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Neoplasm |
Procedure: Laparotomy Procedure: Continuous hyperthermic peritoneal perfusion (CHPP) Drug: Cisplatin Drug: Fluorouracil Drug: Paciltaxel Drug: Oxaliplatin Drug: Leucovorin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Prospective Random Assignment Trial to Study Operative Debuking and Systemic Chemotherapy With or Without Intra-and Peri-Operative Intraperitoneal Chemotherapy for Subjects With Peritoneal Carcinomatosis From Low Grade Gastrointestinal Adenocarcinoma |
| Estimated Enrollment: | 82 |
| Study Start Date: | January 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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 (CHPP) with 250 mg/m2 cisplatin and an intraperitoneal dwell of 5-fluorouracil 800 mg/m2 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Patients will be excluded if they have concomitant medical problems that would place them at unacceptable risk for a major surgical procedure.
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00052962 History of Changes |
| Obsolete Identifiers: | NCT00056108 |
| Other Study ID Numbers: | 030085, 03-C-0085 |
| Study First Received: | January 26, 2003 |
| Last Updated: | February 27, 2012 |
| Health Authority: | United States: Federal Government |
|
Appendiceal Cancer Regional Therapy Carcinomatosis Hyperthermia |
|
Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Carcinoma Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Oxaliplatin Cisplatin Fluorouracil Leucovorin Levoleucovorin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents |