Clinical trial · Interventional
Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer. PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival at 5 years
Secondary outcomes (3)
- measure
- Overall survival at 8 years
- measure
- Tolerability
- measure
- Correlation of clinical, histological, and biological prognostic factors with outcome
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon
* Stage II disease (pT3, N0 or pT4, N0)
* Penetration of the subserosa or serosa
* No lymph node metastases
* At least 12 lymph nodes analyzed
* More than 1 synchronous primary colon tumor allowed
* Staging determined for the more advanced tumor
* Curative radical resection within the past 2-8 weeks required
* Proximal, distal, and radical margins must be free of tumor (R0 resection)
* No rectal tumors
* Gross distal margin of the primary tumor must lie above the peritoneal reflection
* No known familial adenomatous polyposis
* No hereditary nonpolyposis colorectal cancer
* No distant metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000mm\^3
* Hemoglobin ≥ 10 g/dL
Hepatic
* Bilirubin \< 1.25 times upper limit of normal (ULN)
* No known Gilbert's syndrome
Renal
* Creatinine \< 1.25 times ULN
Cardiovascular
* No severe or uncontrolled coronary disease
* No severe heart failure
* No uncontrolled arterial hypertension
* No myocardial infarction within the past year
* No cerebral vascular accident within the past year
* Cardiac arrhythmia allowed provided patient is on proper anticoagulation therapy\* NOTE: \*Aspirin is not considered proper anticoagulation
Gastrointestinal
* No Gardner's syndrome
* No Turcot's syndrome
* No Crohn's disease
* No ulcerative colitis
Other
* No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No other serious disease
* No contraindication to any study drugs
* No known allergy to leucovorin calcium
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 6 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy
Surgery
* See Disease Characteristics
Other
* No other concurrent anticancer therapy
* No concurrent vitamin supplements containing folic acidReferences
Publications (0)
Data not yet available