Clinical trial · Interventional
Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
Drug Treatment for Bowel Cancer: Making the Best Choices When a Milder Treatment is Needed
NCT00070213CI-TRIAL-00054098completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 leucovorin, fluorouracil, capecitabine, and oxaliplatin, 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 whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with 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 |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- MdG (modified de Gramont)
- description
- 2 weekly 5FU/FA schedule
- interventionNames
- Drug: FOLFOX regimen
- Drug: fluorouracil
- Drug: leucovorin calcium
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
- label
- OxMdG (80%) for 12 weeks
- description
- MdG + oxaliplatin
- interventionNames
- Drug: FOLFOX regimen
- Drug: fluorouracil
- Drug: leucovorin calcium
- Drug: oxaliplatin
- Procedure: quality-of-life assessment
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of colorectal adenocarcinoma, defined by 1 of the following: * Prior or current histologically confirmed primary adenocarcinoma of the colon or rectum with clinical/radiological evidence of advanced/metastatic disease * Histologically or cytologically confirmed metastatic adenocarcinoma with clinical/radiological evidence of colorectal primary tumor * Unidimensionally measurable disease * Unfit and unsuitable for full-dose combination chemotherapy, which would include 1 of the following circumstances: * Unsuitable or unwilling to be entered into any full-dose chemotherapy protocol * Ineligible or unsuitable for first-line standard combination as per National Institute of Clinical Excellence guidance PATIENT CHARACTERISTICS: Age * Not specified Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin no greater than 3 times upper limit of normal (ULN) * AST or ALT no greater than 2.5 times ULN Renal * Creatinine clearance greater than 50 mL/min OR * Glomerular filtration rate greater than 30 mL/min Cardiovascular * No uncontrolled angina * No recent myocardial infarction Other * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No partial or complete bowel obstruction * No concurrent severe uncontrolled medical illness that would preclude study treatment * No psychiatric or neurological condition that would preclude giving informed consent or complying with oral study medication * No other prior or concurrent malignant disease that would preclude study treatment or assessment of response * No prior neuropathy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 months since prior adjuvant chemotherapy with fluorouracil with or without leucovorin calcium * More than 1 month since prior rectal chemoradiotherapy with fluorouracil with or without leucovorin calcium * No prior systemic palliative chemotherapy for metastatic disease Endocrine therapy * Not specified Radiotherapy * See Chemotherapy Surgery * Not specified Other * No concurrent brivudine or sorivudine
References
Publications (2)
- RESULTSeymour MT, Thompson LC, Wasan HS, Middleton G, Brewster AE, Shepherd SF, O'Mahony MS, Maughan TS, Parmar M, Langley RE; FOCUS2 Investigators; National Cancer Research Institute Colorectal Cancer Clinical Studies Group. Chemotherapy options in elderly and frail patients with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial. Lancet. 2011 May 21;377(9779):1749-59. doi: 10.1016/S0140-6736(11)60399-1. Epub 2011 May 11. PMID 21570111
- RESULTSeymour MT, Maughan TS, Wasan HS, et al.: Capecitabine (Cap) and oxaliplatin (Ox) in elderly and/or frail patients with metastatic colorectal cancer: the FOCUS2 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-9030, 500s, 2007.