Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Alternate Title

Surgery and Combination Chemotherapy in Treating Patients With Colorectal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed under 75 BEL-GRECR-B EU-96001

Objectives

I.  Determine the efficacy of adjuvant portal chemotherapy with fluorouracil 
(5-FU) and mitomycin and systemic adjuvant chemotherapy with 5-FU/levamisole 
with or without leucovorin in patients with stage II/III colorectal cancer 
(Dukes stage B/C).

Entry Criteria

Disease Characteristics:

Histologically confirmed colorectal carcinoma
  Stage II/III (Dukes' B/C)
  Eligible for curative resection (with at least 2-cm margins for rectal
     cancer)

Prior/Concurrent Therapy:

No prior chemotherapy

Patient Characteristics:

Age:
  Under 75

Performance status:
  Karnofsky 80%-100%

Hematopoietic:
  WBC at least 3,000
  Platelets at least 100,000

Hepatic:
  Bilirubin less than 2 mg/dL

Renal:
  Creatinine less than 1.2 mg/dL

Cardiovascular:
  No cardiopathy

Other:
  No psychiatric disorder that would impede follow-up

Expected Enrollment

800 patients will be accrued.

Outline

Randomized study.  All patients are randomized before surgery to Arms I and II 
and after surgery to Arms III and IV.  Patients with rectal or rectosigmoidal 
tumors receive radiotherapy on Regimen A.  The following acronyms are used:
  CF     Leucovorin calcium, NSC-3590
  5-FU   Fluorouracil, NSC-19893
  LEV    Levamisole, NSC-177023
  MITO   Mitomycin, NSC-26890

Arm I:  Surgery followed by 2-Drug Combination Intraportal Chemotherapy.  
Radical resection; followed by 5-FU; MITO.

Arm II:  Surgery.  Radical resection.

Arm III:  Single-Agent Systemic Chemotherapy with Drug Modulation.  5-FU; with 
LEV. 

Arm IV:  Single-Agent Systemic Chemotherapy with Drug Modulation.  5-FU; with 
LEV; CF.

Regimen A:  Radiotherapy.  Irradiation of tumor bed using linear accelerator 
or Co60 source.

Bury J, Focan C, Beauduin ML, et al.: Portal and systemic chemotherapy for Dukes B2 and C colorectal cancer. An intermediary report on a double randomized trial. [Abstract] Proceedings of the American Society of Clinical Oncology 16 : A942, 1997.

Focan C, Bury J, Beauduin M, et al.: Portal and systemic chemotherapy for Dukes B2 and C colorectal cancer: an intermediary report on a double randomized trial. [Abstract] VIth EORTC GITCCG Symposium 1996: an update after 25 years of experience 76, 1996.

Longrée L, Focan C, Bury J, et al.: Levamisole adds granulocyte toxicity to 5FU-based chemotherapies in adjuvant treatment of Dukes B-C colorectal cancer. A preliminary report. Anticancer Res 15 (4): 1561-4, 1995 Jul-Aug.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Clinique Saint-Joseph

Christian Focan, MD, PhD, Protocol chair		Ph: 32-4-224-8990 Email: Christian.Focan@CHC.be