Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
Phase II-III Study of an Optimized LV-5FU-Oxaliplatin Strategy in Metastatic Colorectal Cancer. Optimox2 Study. C02-2
- 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 oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer. PURPOSE: This randomized phase II/III trial is studying two combination chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Overall survival
- measure
- Time to disease control
- measure
- Response as measured by RECIST criteria
- measure
- Toxicity
- measure
- Quality of life as assessed by EUROQOL- 5 Dimensional Instrument or Functional Assessment of Cancer Therapy-Neurotoxicity module version 4.0 at baseline and periodically during study treatment
- measure
- Pharmaco-economic evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven adenocarcinoma of the colon or rectum
* Metastatic disease
* No metastases involving only the bone
* Inoperable disease (i.e., not suitable for complete surgical resection)
* Measurable or evaluable disease
* Measurable disease defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional CT scan OR ≥ 10 mm by spiral CT scan
* No symptomatic ascites or pleural effusion that has not been evacuated
* No CNS metastasis
PATIENT CHARACTERISTICS:
* WHO OR ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelets ≥ 100,000/mm\^3
* Creatinine \< 3 times upper limit of normal (ULN)
* Alkaline phosphatase \< 5 times ULN
* No peripheral neuropathy ≥ grade 1
* No total or partial bowel obstruction
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled hypercalcemia
* No other concurrent or prior malignancy, except adequately treated carcinoma in situ of the uterine cervix or basal or squamous cell carcinoma of the skin or cancer in complete remission for ≥ 5 years
* No uncontrolled congestive heart failure
* No angina pectoris
* No hypertension
* No arrhythmias
* No history of significant neurologic or psychiatric disorders
* No active infection
* No other serious nonmalignant disease
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy and/or immunotherapy for metastatic disease
* Prior adjuvant chemotherapy allowed provided progression-free interval after completion of adjuvant chemotherapy is \> 6 months
* No other concurrent anticancer treatment
* No participation in another clinical trial with any investigational drug within 30 days prior to randomization
* No other concurrent investigational treatment
* No concurrent radiotherapy
* No concurrent cold cap for prevention of alopecia or iced mouth rinses for prevention of stomatitisReferences
Publications (1)
- RESULTChibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28. PMID 19786657