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

NCT00002525 | Terminated Phase 3 Results DMC

• 3 other identifiers: E1292U10CA023318CDR0000078337
• Study Type: interventional
• Target: 859
• Locations: 1 country
• Sites: 1

Brief Summary

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 evaluate whether perioperative 5-Fluorouracil (5-FU) chemotherapy after curative resection could improve overall survival and disease-free survival in patients with Duke's B3 or C colon cancer.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; stage III colon cancer

Outcome Measures

Primary Outcomes (1)

• 5-year Overall Survival Rate in Patients With Dukes' B3/C Disease

  Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate

  every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Secondary Outcomes (3)

• 5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease

  every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

• 5-year Overall Survival Rate in Patients With Dukes' B2 Disease

  every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

• 5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease

  every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization

Study Arms (2)

Perioperative 5-FU

EXPERIMENTAL

Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5

Drug: fluorouracil; Drug: leucovorin calcium

No perioperative 5-FU

ACTIVE COMPARATOR

Patients receive no perioperative fluorouracil. After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m\^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m\^2 IV push on days 1-5

Drug: fluorouracil; Drug: leucovorin calcium

Interventions

fluorouracil DRUG

Perioperative 5-FU: 600 mg/m\^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m\^2 IV push on days 1-5

Also known as: 5-FU, Adrucil, Efudex

No perioperative 5-FU; Perioperative 5-FU

leucovorin calcium DRUG

given after surgery at dose of 20mg/m\^2 IV push on days 1-5

Also known as: Leucovorin, Wellcovorin, Citrovorum factor, Folinic acid, 5-formyl tetrahydrofolate, LV, LCV

No perioperative 5-FU; Perioperative 5-FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator
• SWOG Cancer Research Network: collaborator
• Cancer and Leukemia Group B: collaborator
• American College of Surgeons: collaborator
• NSABP Foundation Inc: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Study statistician
• Organization: ECOG-ACRIN Statistical Office

617-632-3012

Study Officials

• Mary M. Kemeny, MD, FACS

  SUNY at Stony Brook

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 6, 2004
• Study Start: October 1, 1993
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 28, 2023
• Results First Posted: July 20, 2016

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)