Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer

Sponsor

UNICANCER (Other)

Overall Status

Terminated

CT.gov ID

NCT00005944

Collaborator

(none)

Locations

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Colorectal Cancer Metastatic Cancer Primary Peritoneal Cavity Cancer	Drug: chemotherapy Drug: fluorouracil Drug: leucovorin calcium Drug: mitomycin C Procedure: conventional surgery Procedure: laparoscopic surgery	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence

Actual Study Start Date :

Jul 1, 1999

Actual Primary Completion Date :

Oct 24, 2000

Actual Study Completion Date :

Oct 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Sart-Tilman	Liege	Belgium	B-4000
2	CHR de Besancon - Hopital Jean Minjoz	Besancon	France	25030
3	Institut Bergonie	Bordeaux	France	33076
4	CHU Ambroise Pare	Boulogne Billancourt	France	F-92104
5	Centre Hospitalier Universitaire de Dijon	Dijon	France	21033
6	Centre Hospitalier Regional de Lille	Lille	France	59037
7	Centre Leon Berard	Lyon	France	69373
8	Institut J. Paoli and I. Calmettes	Marseille	France	13273
9	CHU de la Timone	Marseille	France	13385
10	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier	France	34298
11	CRLCC Nantes - Atlantique	Nantes-Saint Herblain	France	44805
12	CHR Hotel Dieu	Nantes	France	44093
13	Hopital L'Archet - 2	Nice	France	F-06202
14	C.H.R. de Nimes - Hopital Caremeau	Nimes	France	30000
15	CHR D'Orleans - Hopital de la Source	Orleans	France	45067
16	Centre Hospitalier Universitaire	Reims	France	51092
17	Centre Paul Strauss	Strasbourg	France	67085
18	Institut Gustave Roussy	Villejuif	France	F-94805