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 November 04, 2024

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).

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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