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PHASE III INTERGROUP PROSPECTIVELY RANDOMIZED TRIAL OF PERI-OPERATIVE 5-FU AFTER CURATIVE RESECTION, FOLLOWED BY 5-FU/LEVAMISOLE FOR PATIENTS WITH COLON CANCER


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

PHASE III INTERGROUP PROSPECTIVELY RANDOMIZED TRIAL OF PERI-OPERATIVE 5-FU AFTER CURATIVE RESECTION, FOLLOWED BY 5-FU/LEVAMISOLE FOR PATIENTS WITH COLON CANCER


OBJECTIVES: I. Compare survival, disease free survival, and locoregional and distant
metastases recurrence rates of patients with stage IIC or stage III colon cancer treated
with curative colon resection with or without perioperative fluorouracil, followed by
fluorouracil and leucovorin calcium. II. Compare survival and disease free survival in
patients with stage IIB colon cancer treated with curative colon resection with or without
perioperative fluorouracil.

OUTLINE: This is a randomized study. Patients undergo curative colon resection via
laparotomy. Patients are randomized to 1 of 2 arms. Arm I: Within 24 hours of the colon
resection, patients receive perioperative fluorouracil IV over 24 hours for 7 days. Arm II:
Patients receive no perioperative fluorouracil. After surgery, patients with stage I, stage
IIA, or stage IV colon cancer are immediately removed from study. Patients with stage IIB,
IIC, or III colon cancer are reregistered within 35 days postoperatively. Beginning 21-35
days after surgery, patients with stage IIC or III disease receive leucovorin calcium IV
bolus immediately followed by fluorouracil IV bolus on days 1-5. Courses repeat every 28
days for a total of 6 courses in the absence of disease progression or unacceptable
toxicity. Patients with stage IIB disease do not receive adjuvant fluorouracil and
leucovorin calcium. Patients are followed every 3 months for 2 years, then every 6 months
for 2 years, and then annually.

PROJECTED ACCRUAL: A total of 800-2,000 patients (at least 400 per treatment arm) will be
accrued for this study over 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Adenocarcinoma of the colon documented by colonoscopy or barium
enema Tumor either considered resectable or totally resected within 24 hours prior to
study No dual primary tumors Randomization within 2 weeks prior to surgery or within 24
hours after surgery required Patients randomized after surgery must meet the following
criteria: Complete resection performed with no evidence of residual disease or distant
metastases Distal margin of tumor above the peritoneal reflection in area of rectum No
free perforation Intestinal obstruction allowed Preliminary or complementary colostomy
allowed Concurrent registration for E-3293 strongly recommended

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC
at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than
2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: No prior nonmalignant
systemic disease that would preclude use of chemotherapy No second malignancy within 5
years except: Superficial nonmelanomatous skin cancer Carcinoma in situ of the cervix Not
pregnant or nursing Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
fluorouracil No other prior or concurrent chemotherapy for this malignancy Endocrine
therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy for this
malignancy Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mary M. Kemeny, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Queens Cancer Center of Queens Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000078337

NCT ID:

NCT00002525

Start Date:

August 1993

Completion Date:

Related Keywords:

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

Name

Location

Loyola University Medical CenterMaywood, Illinois  60153