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Search / Trial NCT00002525

Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed

Launched by ECOG-ACRIN CANCER RESEARCH GROUP · Apr 5, 2004

Trial Information

Current as of April 03, 2025

Terminated

Keywords

Stage Ii Colon Cancer Stage Iii Colon Cancer

ClinConnect Summary

OBJECTIVES:

I. To determine if adjuvant therapy with one week of continuous 5-FU given within 24 hours of a curative colon resection followed by 6 months of 5-FU/leucovorin is effective in prolonging the disease-free survival and increasing overall survival in patients with Dukes' B3 or C colon cancer, when compared to patients who are treated with 5-FU/leucovorin only.

II. 1. To determine if a week of perioperative continuous 5-FU affects disease-free survival and overall survival in patients with Dukes' B2 colon cancer.

OUTLINE: This is an open-label, randomized phase III study. Patien...

Gender

ALL

Eligibility criteria

  • Eligibility Criteria for Randomization:
  • Inclusion Criteria:
  • Adenocarcinoma of the colon documented by colonoscopy or barium enema
  • Tumor either considered resectable or totally resected within 24 hours prior to study
  • 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 E3293 strongly recommended
  • Age 18 and over
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate organ function based on the following tests within 2 weeks prior to randomization
  • White Blood Cell (WBC) at least 3,000/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 2.0 mg/dL
  • Creatinine no greater than 2.0 mg/dL
  • No second malignancy within 5 years except: superficial non-melanomatous skin cancer and carcinoma in situ of the cervix
  • Fertile patients must use adequate contraception
  • Exclusion Criteria:
  • Dual primary tumors
  • Prior nonmalignant systemic disease that would preclude use of chemotherapy
  • Pregnant or nursing
  • Prior fluorouracil
  • Other prior or concurrent chemotherapy for this malignancy
  • Prior or concurrent radiotherapy for this malignancy
  • Eligibility Criteria for Re-registration for Patients Randomized Pre-operatively:
  • Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution.
  • Must be re-registered \< 35 days after surgery.
  • ECOG performance status of 0-2.
  • Complete resection must have been performed with no evidence of residual disease or distant metastasis.
  • Distal margin of the tumor must not extend below the peritoneal reflection in the area of the rectum.
  • Single primary colon carcinoma without free perforation demonstrated. Patients with intestinal obstruction are eligible. Preliminary or complementary colostomy dose not preclude entry of a patient.
  • Have WBC \> 3000/mm\^3, platelets \> 100,000/mm\^3, adequate renal (serum creatinine \<= 2.0mg/dL) and hepatic function (bilirubin \<= 2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only).
  • Eligibility Criteria for Re-registration for Patients Randomized Post-operatively:
  • Must have pathologic classification of Dukes' B2, B3, or C disease by the contributing institution.
  • Patient must be re-registered \< 35 days after surgery.
  • ECOG performance status of 0-2.
  • Started perioperative 5-FU, if assigned, within 24 hours of surgery.
  • Have WBC \> 3000/mm\^3, platelets \> 100,000/mm\^3, adequate renal (serum creatinine \<= 2.0mg/dL) and hepatic function (bilirubin \< =2.0mg/dL), within one week prior to beginning adjuvant chemotherapy (For Dukes' B3 and C patients only).

Trial Officials

Mary M. Kemeny, MD, FACS

Study Chair

SUNY at Stony Brook

About Ecog Acrin Cancer Research Group

The ECOG-ACRIN Cancer Research Group is a prominent clinical trial sponsor dedicated to advancing cancer research through innovative clinical trials and rigorous scientific inquiry. As a collaborative network of researchers, healthcare professionals, and institutions, ECOG-ACRIN focuses on improving cancer treatment and patient outcomes by conducting high-quality, multicenter studies. Their research spans various cancer types and includes a wide array of therapeutic approaches, emphasizing the integration of cutting-edge methodologies and patient-centered care. Committed to fostering collaboration and sharing knowledge, ECOG-ACRIN plays a vital role in transforming cancer care and enhancing the understanding of cancer biology.

Locations

Maywood, Illinois, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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