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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2001 by Eastern Cooperative Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Southwest Oncology Group
Cancer and Leukemia Group B
NSABP Foundation Inc
American College of Surgeons
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00002525
First received: November 1, 1999
Last updated: April 2, 2013
Last verified: September 2001
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with that of no further therapy in treating patients who have stage II or stage III colon cancer that can be surgically removed.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Procedure: surgical procedure
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PHASE III INTERGROUP PROSPECTIVELY RANDOMIZED TRIAL OF PERI-OPERATIVE 5-FU AFTER CURATIVE RESECTION, FOLLOWED BY 5-FU/LEVAMISOLE FOR PATIENTS WITH COLON CANCER

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Study Start Date: August 1993
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002525

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Southwest Oncology Group
Cancer and Leukemia Group B
NSABP Foundation Inc
American College of Surgeons
Investigators
Study Chair: Mary M. Kemeny, MD, FACS Queens Cancer Center of Queens Hospital
Study Chair: Robert P. Whitehead, MD UMC Southwest Cancer and Research Center
Study Chair: Terry Mamounas, MD, MPH, FACS Aultman Cancer Center at Aultman Hospital
Study Chair: Francis Joseph Harford, MD Loyola University
  More Information

Additional Information:
Publications:
Kemeny M, Ibrahim J, Benson AB, et al.: Post-operative complications of continuous infusion 5 FU following curative resection of colon cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 16: A923, 260a, 1997.

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00002525     History of Changes
Other Study ID Numbers: CDR0000078337, E-1292, ACOSOG-E1292, CLB-9395, NSABP-C1-63, SWOG-9250, INT-0136
Study First Received: November 1, 1999
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Eastern Cooperative Oncology Group:
stage II colon cancer
stage III colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Fluorouracil
Levoleucovorin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014