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Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer

Phase 3
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole Versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer

OBJECTIVES: I. Compare overall and disease free survival in patients with completely
resected stage II or III colon cancer randomized to adjuvant chemotherapy with bolus
fluorouracil and leucovorin calcium with levamisole vs continuous infusion fluorouracil with

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, T stage (T1 vs T2 vs T3 vs T4a), N stage (N0 vs N1 vs N2-3), and time from surgery
until registration (21-28 vs 29-35 days). Patients are randomized to one of two treatment
arms. Arm I: Patients receive leucovorin calcium IV immediately followed by fluorouracil IV
on days 1 through 5 of weeks 1, 5, 9, 14, 19, and 24, and oral levamisole 3 times a day for
3 days on days 1-3. Courses repeat every 2 weeks for 6 months. Arm II: Patients receive
levamisole as in arm I plus fluorouracil by continuous IV infusion for 8 weeks. Treatment
with fluorouracil repeats every 10 weeks for 3 courses. Treatment continues in the absence
of disease progression or unacceptable toxicity. Patients are followed at 9 months and 12
months, then every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the study over
approximately 5.5 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven resectable stage II or III adenocarcinoma
of the colon Caudal margin of the primary tumor must lie above the peritoneal reflection
Must have pathologic confirmation of either N1-3 (stage III), or if N0, must have T3-T4
(stage II) with bowel obstruction or perforation Obstruction documented as: At least 75%
colon or small bowel obstruction on x-ray and/or endoscopy Significant bowel dilatation
surgically documented Significant obstruction described in the pathology report
Perforation documented by gross operative/pathologic evidence of a colon wall defect with
associated abscess or peritonitis Complete en bloc resection by laparotomy required No
laparoscopic colectomy without prior surgery on protocol SWOG-9411 No gross or microscopic
residual disease No distant peritoneal metastases (stage IV) even if grossly resectable No
requirement to open the pelvic peritoneum to define the extent of disease No extrapelvic
nodal metastasis unless resected en bloc with the primary tumor No distant metastases No
other diagnosis of stage II-III colon cancer within the past 5 years May have undergone
complete surgical resection at least 5 years prior to study Completely resected prior or
synchronous stage 0-I colon cancer eligible

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: WBC (white
blood cell) at least 3,500/mm3 Platelet count at least within the lower limit of normal
Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST (angiotensin
sensitivity test) no greater than 2 times ULN Alkaline phosphatase no greater than 2
times ULN Renal: Creatinine no greater than 2 times ULN Other: No organic brain syndrome,
Alzheimer's disease, or other altered mental status No second malignancy within 5 years
except: Adequately treated nonmelanomatous skin cancer Adequately treated carcinoma in
situ of the cervix Not pregnant or nursing Negative pregnancy test Effective contraception
required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
fluorouracil or other chemotherapy for cancer No concurrent chemotherapy Endocrine
therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy for cancer
Surgery: Complete en bloc resection required (see Disease Characteristics)

Type of Study:


Study Design:

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

Outcome Measure:

Compare effectiveness of bolus 5-FU, leucovorin, levamisole vs continuous infusion 5-FU, levamisole as adjuvant therapy for patients with colon cancer, measured in overall survival

Outcome Time Frame:

At death

Safety Issue:


Principal Investigator

Elizabeth A. Poplin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

December 1994

Completion Date:

March 2005

Related Keywords:

  • Colorectal Cancer
  • stage II colon cancer
  • stage III colon cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms



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