Clinical trial · Interventional
Perioperative Chemotherapy in Treating Patients With Colon Cancer That Can Be Surgically Removed
Phase III Intergroup Prospectively Randomized Trial of Perioperative 5-FU After Curative Resection, Followed by 5-FU/Leucovorin for Patients With Colon Cancer
NCT00002525CI-TRIAL-00067641terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped before reaching its accrual goal due to slow accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Perioperative 5-FU
- description
- 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
- interventionNames
- Drug: fluorouracil
- Drug: leucovorin calcium
- type
- ACTIVE_COMPARATOR
- label
- No perioperative 5-FU
- description
- 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
- interventionNames
- Drug: fluorouracil
- Drug: leucovorin calcium
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTKemeny 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.