Clinical trial · Interventional
Feasibility Study of mFOLFOX6 in Patients With Advanced Colorectal Cancer
Feasibility Study of mFOLFOX6 (Oxaliplatin Combined With l-Leucovorin (l-LV) and 5-Fluorouracil) in Patients With Advanced Colorectal Cancer
NCT00209703CI-TRIAL-00000326terminatedPhase 2ClinicalTrials.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)
We performed a feasibility study of mFOLFOX6 in advanced colorectal cancer in Japan and to estimate the safety and efficacy of this regimen.
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 |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| l-Leucovorin | Drug | Levoleucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence and severity of adverse event
Secondary outcomes (1)
- measure
- Determine the clinical response rate, disease-free survival(DFS), overall survival(OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological diagnosis of colorectral adenocarcinoma. 2. Measurable or assessable lesions. 3. Age: 15 \~ 75 years. 4. Performance Status (ECOG): 0 \~ 2. 5. Prior chemotherapy within 2 regimens. 6. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 3.0mg/dl. Creatinine within the upper limit of normal. Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for \>8 weeks. (11) Able to give written informed consent. Exclusion Criteria: 1. Severe pleural effusion or ascites. 2. Metastasis to the central nervous system (CNS). 3. Active gastrointestinal bleeding. 4. Active infection. 5. Uncontrolled ischemic heart disease. 6. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 7. Active multiple cancer. 8. Severe mental disorder. 9. Pregnancy, possible pregnancy, or breast-feeding. 10. Patients with neuropathy ≥ grade 2 11. Judged to be ineligible for this protocol by the attending physician.
References
Publications (0)
Data not yet available
No reference posted for this study.