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

This study is ongoing, but not recruiting participants.

Sponsored by: Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005944
  Purpose

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: fluorouracil
Drug: leucovorin calcium
Drug: mitomycin C
Procedure: chemotherapy
Procedure: conventional surgery
Procedure: laparoscopic surgery
Phase II

MedlinePlus related topics:   Cancer    Colorectal Cancer   

Drug Information available for:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Fluorouracil    Calcium gluconate    Mitomycin    Mitomycins   

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 1999

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.

  Eligibility
Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005944

Locations
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

Sponsors and Collaborators
Federation Nationale des Centres de Lutte Contre le Cancer

Investigators
Study Chair:     Dominique Elias, MD     Institut Gustave Roussy    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067833, FRE-FNCLCC-97018, EU-20010
First Received:   July 5, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005944
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer  
recurrent rectal cancer  
adenocarcinoma of the colon  
adenocarcinoma of the rectum
liver metastases
peritoneal cavity cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Intestinal Diseases
Mitomycins
Rectal Diseases
Recurrence
Intestinal Neoplasms
Digestive System Diseases
Fluorouracil
Mitomycin
Neoplasm Metastasis
Gastrointestinal Neoplasms
Adenocarcinoma
Rectal cancer
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Vitamin B Complex
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Vitamins
Therapeutic Uses
Micronutrients
Alkylating Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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