CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER
N/A
N/A
Both
Colorectal Cancer
Trial Information
CHEMOTHERAPY CHOICES IN ADVANCED COLORECTAL CANCER: A RANDOMISED TRIAL COMPARING 2 DURATIONS AND 3 SYSTEMIC CHEMOTHERAPY REGIMENS IN THE PALLIATIVE TREATMENT OF ADVANCED COLORECTAL CANCER
OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or
recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs.
continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life
of patients with stable or responding disease after 12 weeks of initial treatment randomized
to receive 12 additional weeks of chemotherapy vs. no further treatment.
OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomized to one of three treatment regimens. The first group receives
leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group
receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694
every 21 days for a total of 4 courses. Patients without progressive disease or excessive
toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy
in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no
further therapy, until evidence of disease progression. Patients are followed every 6 weeks.
PROJECTED ACCRUAL: A total of 900 patients will be entered.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum in
one of the following categories: Locally advanced, metastatic, or recurrent disease
suitable only for palliative chemotherapy Evaluable disease outside prior radiotherapy
field Patients with disease confined to the liver are referred to protocol MRC-CR05
PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy:
Greater than 3 months Hematopoietic: WBC at least 4,000 ANC at least 2,000 Platelets at
least 100,000 Hepatic: Not specified Renal: Creatinine no greater than 1.25 times normal
OR Creatinine clearance greater than 65 mL/min Cardiovascular: No uncontrolled heart
failure No uncontrolled angina Other: No uncontrolled medical illness (including
infection) Able and willing to complete quality-of-life questionnaires No prior or
concurrent malignancy likely to interfere with protocol treatment or evaluation
PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy except fluorouracil-based
adjuvant regimen (e.g., QUASAR) At least 6 months since chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Timothy Maughan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Velindre NHS Trust
Authority:
United States: Federal Government
Study ID:
CDR0000065216
NCT ID:
NCT00002893
Start Date:
June 1995
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage III colon cancer
- stage IV colon cancer
- stage III rectal cancer
- stage IV rectal cancer
- recurrent colon cancer
- recurrent rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- Colorectal Neoplasms
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