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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005944 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Metastatic Cancer Peritoneal Cavity Cancer |
Drug: chemotherapy Drug: fluorouracil Drug: leucovorin calcium Drug: mitomycin C Procedure: conventional surgery Procedure: laparoscopic surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence |
Study Start Date: | November 1999 |
OBJECTIVES: I. Compare the effect of second look surgery with or without intraperitoneal mitomycin and fluorouracil on the 3 year survival rate of patients with colorectal cancer who are at high risk for peritoneal cavity cancer. II. Compare the quality of life of patients treated with these regimens. III. Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, risk group, presence of symptoms (yes vs no), and isolated disease (yes vs no). After primary surgery, all patients receive 6 months of chemotherapy consisting of leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks. Patients then undergo second look surgery or laparoscopy at 8-12 months. Second look surgery or laparoscopy may be performed earlier if markers increase progressively for unknown reasons or symptoms of peritoneal cancer occur. Patients with recurrent disease that can be resected are randomized to one of two treatment arms. Patients with no residual disease or with unresectable disease are followed for survival. Arm I: Patients undergo complete resection of all detectable lesions followed immediately by intraperitoneal (IP) mitomycin on day 0 and fluorouracil IP on days 1-4. Patients also receive systemic chemotherapy consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Systemic chemotherapy repeats every 2 weeks for 6 months. Arm II: Patients undergo complete or partial resection and then receive systemic chemotherapy as in arm I. Quality of life is assessed at baseline and then every 4 months for 3 years. All patients (including nonrandomized patients) are followed every 4 months for 3 years.
PROJECTED ACCRUAL: A total of 152 patients (76 randomized) will be accrued for this study.
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Primary diagnosis of adenocarcinoma of the colon or rectum and meeting one of the following risk criteria during the primary surgery: Perforated bowel (spontaneous or not) Occlusion Peritoneal deposits Invasion of serosa of more than 4 cm diameter Concurrent ovarian metastases Randomization eligibility: Presence of proven recurrent peritoneal disease (only one micronodule of 1 mm sufficient) at second look laparotomy Total resection of macroscopic lesions possible (local recurrence, lymph node or hepatic metastases)
PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No cardiac condition that would increase surgical risk Pulmonary: No pulmonary condition that would increase surgical risk Other: No other condition that would increase surgical risk No other malignancy within the past 5 years except basal cell skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No concurrent anticancer radiotherapy Surgery: See Disease Characteristics
Belgium | |
CHU Sart-Tilman | |
Liege, Belgium, B-4000 | |
France | |
C.H.R. de Nimes - Hopital Caremeau | |
Nimes, France, 30000 | |
Centre Hospitalier Regional de Lille | |
Lille, France, 59037 | |
Centre Hospitalier Universitaire | |
Reims, France, 51092 | |
Centre Hospitalier Universitaire de Dijon | |
Dijon, France, 21033 | |
Centre Leon Berard | |
Lyon, France, 69373 | |
Centre Paul Strauss | |
Strasbourg, France, 67085 | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 | |
CHR D'Orleans - Hopital de la Source | |
Orleans, France, 45067 | |
Institut J. Paoli and I. Calmettes | |
Marseille, France, 13273 | |
CHR Hotel Dieu | |
Nantes, France, 44093 | |
CHU Ambroise Pare | |
Boulogne Billancourt, France, F-92104 | |
CHU de la Timone | |
Marseille, France, 13385 | |
CRLCC Nantes - Atlantique | |
Nantes-Saint Herblain, France, 44805 | |
Hopital L'Archet - 2 | |
Nice, France, F-06202 | |
Institut Bergonie | |
Bordeaux, France, 33076 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
CHR de Besancon - Hopital Jean Minjoz | |
Besancon, France, 25030 |
Study Chair: | Dominique Elias, MD | Institut Gustave Roussy |
Study ID Numbers: | CDR0000067833, FRE-FNCLCC-97018, EU-20010 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005944 History of Changes |
Health Authority: | United States: Federal Government |
recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon |
adenocarcinoma of the rectum liver metastases peritoneal cavity cancer |
Antimetabolites Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Leucovorin Rectal Diseases Mitomycins Anti-Bacterial Agents Vitamins Peritoneal Diseases Mitomycin Neoplasm Metastasis Micronutrients Alkylating Agents |
Vitamin B Complex Digestive System Neoplasms Rectal Neoplasm Trace Elements Intestinal Diseases Abdominal Neoplasms Immunosuppressive Agents Intestinal Neoplasms Recurrence Calcium, Dietary Digestive System Diseases Rectal Cancer Fluorouracil Gastrointestinal Neoplasms Peritoneal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Leucovorin Antibiotics, Antineoplastic Rectal Diseases Neoplastic Processes Neoplasms by Site Pathologic Processes Vitamins |
Therapeutic Uses Peritoneal Diseases Mitomycin Neoplasm Metastasis Micronutrients Alkylating Agents Nucleic Acid Synthesis Inhibitors Vitamin B Complex Digestive System Neoplasms Growth Substances Enzyme Inhibitors Intestinal Diseases Abdominal Neoplasms Immunosuppressive Agents Intestinal Neoplasms |