Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Recurrent Metastatic Colorectal Cancer
Multicentre Phase III Comparing To Therapeutic Sequence: Folfiri Following of Folfox6 (Group A) and Folfox6 Following Of (Group B) For Metastatic Colorectal Cancer
- 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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known whether receiving irinotecan with fluorouracil and leucovorin is more effective than receiving oxaliplatin with fluorouracil and leucovorin in treating recurrent metastatic colorectal cancer PURPOSE: Randomized phase III trial to compare the effectiveness of irinotecan with oxaliplatin followed by fluorouracil and leucovorin in treating patients with recurrent metastatic colorectal 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven recurrent stage IV adenocarcinoma of the colon and rectum No CNS metastases Bidimensionally measurable lesion (at least 2 cm in dimension) or evaluable disease (as malignant ascites or bone metastases) as documented by CT or MRI Must be outside prior radiotherapy field PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Alkaline phosphatase no greater than 3 times normal SGOT/SGPT no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled congestive heart failure or angina pectoris in the past 6 months No hypertension or arrhythmia in the past 6 months Neurologic: No peripheral neuropathy No significant neurologic or psychiatric disorder Other: No complete or partial obstruction of the bowel No serious nonmalignant disease No active infection No second malignancy except in situ cervical carcinoma or nonmelanomatous skin carcinoma No chronic diarrhea Not pregnant or nursing Fertile women must use adequate contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for metastatic disease Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy with no disease progression or after metastatic liver resection No prior chemotherapy with oxaliplatin or irinotecan Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since surgery Other: At least 30 days since use of investigational agent
References
Publications (0)
Data not yet available