Clinical trial · Interventional
Combination Chemotherapy With or Without Irinotecan in Treating Patients With Stage III Colon Cancer
Phase III Randomized Study of Intensive Adjuvant Chemotherapy for Resected Colon Cancer at High Risk of Recurrence
- 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 use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without irinotecan in treating colon cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without irinotecan in treating patients who have stage III 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven stage III adenocarcinoma of the colon that has been curatively resected within past 42 days * No metastatic disease * Node positive * No more than 4 nodes affected (Tx, N2, M0) AND/OR * N1 or N2 with perforation and/or occlusion * No prior rectal cancer within 10 cm of anal margin or that was treated with preoperative radiotherapy * No prior inflammatory disease of the intestine PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.25 times upper limit of normal (ULN) * SGOT and SGPT less than 3 times ULN * Alkaline phosphatase less than 3 times ULN Renal: * Not specified Cardiovascular: * No myocardial infarction within past 6 months * No insufficient cardiac function Other: * No other serious medical illness * No active infection * No other malignancy except skin cancer or carcinoma in situ of the cervix * No psychological or social condition that would preclude study * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics * No prior extensive intestinal resection
References
Publications (2)
- RESULTYchou M, Raoul JL, Douillard JY, Gourgou-Bourgade S, Bugat R, Mineur L, Viret F, Becouarn Y, Bouche O, Gamelin E, Ducreux M, Conroy T, Seitz JF, Bedenne L, Kramar A. A phase III randomised trial of LV5FU2 + irinotecan versus LV5FU2 alone in adjuvant high-risk colon cancer (FNCLCC Accord02/FFCD9802). Ann Oncol. 2009 Apr;20(4):674-80. doi: 10.1093/annonc/mdn680. Epub 2009 Jan 29. PMID 19179549
- RESULTCote JF, Kirzin S, Kramar A, Mosnier JF, Diebold MD, Soubeyran I, Thirouard AS, Selves J, Laurent-Puig P, Ychou M. UGT1A1 polymorphism can predict hematologic toxicity in patients treated with irinotecan. Clin Cancer Res. 2007 Jun 1;13(11):3269-75. doi: 10.1158/1078-0432.CCR-06-2290. Epub 2007 May 17. PMID 17510208