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A Clinical Trial Comparing Oral Uracil/Ftorafur (UFT) Plus Leucovorin (LV) With 5-Fluorouracil (5-FU) Plus LV in the Treatment of Patients With Stages II And III Carcinoma of the Colon

Phase 3
Not Enrolling
Colorectal Cancer

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Trial Information

A Clinical Trial Comparing Oral Uracil/Ftorafur (UFT) Plus Leucovorin (LV) With 5-Fluorouracil (5-FU) Plus LV in the Treatment of Patients With Stages II And III Carcinoma of the Colon

OBJECTIVES: I. Compare the relative efficacy of oral uracil/tegafur (UFT) with leucovorin
(CF) vs. fluorouracil (5-FU) with CF in prolonging overall and disease-free survival in
patients with potentially curatively resected stage II/III adenocarcinoma of the colon. II.
Compare the prognostic significance of several biomarkers alone or in combination, including
DNA mismatch repair gene mutations, p53, deleted colon cancer gene, proliferation status,
and thymidylate synthase, in patients treated with UFT/CF vs. 5-FU/CF. III. Evaluate the
relationships of various biomarkers to each other and their association with patient and
tumor characteristics. IV. Compare quality of life in patients treated with UFT/CF vs.

OUTLINE: This is a randomized study. Patients are stratified by number of positive lymph
nodes and participating institution. For the quality-of-life portion of the study, patients
are stratified by age, sex, and ethnicity. Treatment begins within 6 weeks after curative
resection and within 1 week of randomization. Patients are randomly assigned to one of two
groups. The first group receives intravenous leucovorin followed by intravenous fluorouracil
weekly for 6 weeks. Treatment repeats every 8 weeks for a total of 3 courses. The second
group receives oral uracil/tegafur, and oral leucovorin every 8 hours for 28 days. Treatment
repeats every 5 weeks for a total of 5 courses. No concurrent halogenated antiviral agents
(e.g., sorivudine) are permitted. After completing treatment, patients complete
quality-of-life questionnaires at one year.

PROJECTED ACCRUAL: Approximately 1,500 patients will be entered over 3 years to provide
1,452 evaluable patients.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon that has
been curatively resected within 42 days prior to entry, as follows: Stage II (T3-4 N0 M0,
Modified Astler-Coller B2/3), i.e., tumor invasion of the wall of the colon or extension
into the pericolonic tissue Stage III (any T N1-3 M0), i.e., tumor invasion of any depth
No sarcoma, lymphoma, or carcinoid histology No laparoscopically assisted colectomy unless
performed on protocol NCCTG-934653 (intergroup study INT-0146) Entire tumor located above
the peritoneal reflection on surgical exploration or more than 15 cm from anal verge on
endoscopy Involved adjacent structures (e.g., bladder, small intestine, ovary) removed en
bloc with histologically negative margins More than 1 synchronous primary colon tumor
allowed Most advanced tumor used for stage assignment No previous or synchronous rectal
cancer Intestinal obstruction allowed Preliminary or complementary colostomy allowed
Walled-off perforation allowed No free perforation, i.e., free air or fluid in abdomen No
prior invasive colon or rectal malignancy regardless of disease-free interval

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
At least 10 years (excluding cancer diagnosis) Hematopoietic: WBC at least 4,000/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST or ALT normal Renal:
Creatinine normal Cardiovascular: No active ischemic heart disease No NYHA class III/IV
status No myocardial infarction within 6 months No symptomatic arrhythmia within 6 months
Other: No nonmalignant systemic disease that precludes protocol treatment No psychiatric
or addictive disorder that precludes informed consent No second malignancy within 10 years
except: Effectively treated nonmelanomatous skin cancer Surgically cured carcinoma in situ
of the cervix Lobular carcinoma in situ of the breast No pregnant women Effective
contraception required of fertile patients

PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy or

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare the relative efficacy of UFT + LV with that of 5-FU + LV in prolonging disease-free survival and survival

Safety Issue:


Principal Investigator

Michael J. O'Connell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Allegheny Cancer Center at Allegheny General Hospital


United States: Federal Government

Study ID:




Start Date:

February 1997

Completion Date:

April 2009

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • adenocarcinoma of the colon
  • Colonic Neoplasms
  • Colorectal Neoplasms