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Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum


Phase 2
N/A
N/A
Open (Enrolling)
Both
Carcinoma of the Appendix, Colorectal Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum


OBJECTIVES: I. Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal
mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal
cancer originating from the colorectum.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center and mode of surgery. Patients are randomized to one of two treatment arms. Arm I:
Patients undergo complete resection of tumor on day 0. Patients then receive mitomycin
intraperitoneally (IP) over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5.
Patients then receive one of three systemic chemotherapy regimens for 6 months: Regimen I:
Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on
days 1 and 2. Treatment repeats every 2 weeks. Regimen II: Patients receive fluorouracil IV
continuously for 7 weeks. Treatment repeats every 8 weeks. Regimen III: Leucovorin calcium
and fluorouracil are administered as per standard procedure. Arm II: Patients receive
treatment as in arm I but without early intraperitoneal chemotherapy. Patients are followed
every 3 months for 2 years.

PROJECTED ACCRUAL: At least 90 patients (45 per arm) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven peritoneal cancer that is amenable to total
resection Originated as colorectal adenocarcinoma or cancer of the appendix No diffuse
(unresectable) tumors No microscopic cancer only No hepatic, lymph node, or extraabdominal
metastases on the preoperative work-up No primitive peritoneal mesothelioma No peritoneal
pseudomyxomas or ascites No cancer that originates as ovarian or neuroendocrine cancer,
especially sarcomas (intra- or retroperitoneal) Complete resection of tumor deposit No
originating cancer of unknown origin

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
expectancy: Not specified Hematopoietic: WBC greater than 1,500/mm3 Platelet count greater
than 100,000/mm3 No chronic hematologic disorder No coagulation disorder Hepatic: Not
specified Renal: Creatinine less than 1.36 mg/dL Other: No significant medical condition
that would preclude study

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Dominique Elias, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

United States: Federal Government

Study ID:

CDR0000068124

NCT ID:

NCT00006112

Start Date:

January 1996

Completion Date:

Related Keywords:

  • Carcinoma of the Appendix
  • Colorectal Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • carcinoma of the appendix
  • primary peritoneal cavity cancer
  • Carcinoma
  • Colorectal Neoplasms
  • Peritoneal Neoplasms
  • Colonic Neoplasms

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