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

NCT00005944 | Terminated Phase 2

• 3 other identifiers: CDR0000067833FRE-FNCLCC-97018EU-20010
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 18

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.

Conditions

Colorectal Cancer; Metastatic Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent colon cancer; recurrent rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; liver metastases; primary peritoneal cavity cancer

Interventions

chemotherapy DRUG

fluorouracil DRUG

leucovorin calcium DRUG

mitomycin C DRUG

conventional surgery PROCEDURE

laparoscopic surgery PROCEDURE

Eligibility Criteria

• Age: 0 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (18)

CHU Sart-Tilman

Liège, B-4000, Belgium

Location

CHR de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21033, France

Location

Centre Hospitalier Regional de Lille

Lille, 59037, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Hopital L'Archet - 2

Nice, F-06202, France

Location

C.H.R. de Nimes - Hopital Caremeau

Nîmes, 30000, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Centre Hospitalier Universitaire

Reims, 51092, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Drug Therapy; Fluorouracil; Leucovorin; Mitomycin; Laparoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Dominique Elias, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: March 24, 2004
• Study Start: July 1, 1999
• Primary Completion: October 24, 2000
• Study Completion: October 1, 2003
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

BE (1); FR (17)