Clinical trial · Interventional
Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer
Randomized Phase II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) Versus 5-FU, l-LV and Oxaliplatin Combination Therapy (mFOLFOX6) in Patients With Untreated Metastatic Colorectal Cancer
NCT00721916CI-TRIAL-00008404completedPhase 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)
This is a randomized, multicenter study designed to evaluate the progression free survival of the SOL group (S-1, Leucovorin, and Oxaliplatin) compared with the mFOLFOX6 group (5-FU, l-LV and Oxaliplatin) as first-line treatment of 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin) | Drug | — | UNRESOLVED |
| SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
- interventionNames
- Drug: SOL(The combination therapy of S-1, Leucovorin, and Oxaliplatin)
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
- interventionNames
- Drug: mFOLFOX6(The combination therapy of 5-FU, l-LV and Oxaliplatin)
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- Until progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proved adenocarcinoma (colorectal cancer). * Age: 20 ≤ at enrollment. * No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded. * At least one measurable lesion by RECIST criteria Exclusion Criteria: * Serious drug hypersensitivity. * Prior history of peripheral neuropathy. * Diarrhea . * Simultaneously active double cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.