Clinical trial · Interventional
Comparing Two Combination Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
Phase III Study of An Optimized LV-5FU-Oxaliplatin Regimen in Metastatic Colorectal Cancer. C99-1.
- 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 which regimen of combination chemotherapy is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum * Bidimensionally measurable or evaluable disease outside previously irradiated area * No bone metastasis as target lesion * At least 1 cm if spiral CT scan OR * At least 2 cm if conventional CT scan * No CNS metastasis * No symptomatic ascites or pleural effusion that is not evacuated * No total or partial bowel obstruction PATIENT CHARACTERISTICS: Age: * 18 to 80 Performance status: * ECOG 0-2 * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Alkaline phosphatase less than 5 times upper limit of normal (ULN) Renal: * Creatinine less than 3 times ULN * No uncontrolled hypercalcemia Cardiovascular: * No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias Other: * No peripheral sensory neuropathy * No prior significant neurologic or psychiatric disorders * No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma * No active infection * No other concurrent serious disease * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for metastatic disease Chemotherapy: * Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course * No prior oxaliplatin or irinotecan * No prior chemotherapy for metastatic disease * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Concurrent surgery allowed Other: * At least 30 days since other prior investigational drugs * No other concurrent investigational treatment * No other concurrent antitumoral treatment
References
Publications (0)
Data not yet available