Clinical trial · Interventional
Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer
A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer
NCT00677144CI-TRIAL-00008219completedPhase 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)
The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent 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 Neoplasm | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OS (oxalipaltin+S-1) | Drug | — | UNRESOLVED |
| XELOX (oxalipaltin+capecitabine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OS (oxalipaltin+S-1)
- description
- OS (oxaliplatin + S-1): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days
- interventionNames
- Drug: OS (oxalipaltin+S-1)
- type
- ACTIVE_COMPARATOR
- label
- XELOX (oxalipaltin+capecitabine)
- description
- XELOX (oxalipaltin+capecitabine): Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
- interventionNames
- Drug: XELOX (oxalipaltin+capecitabine)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred * Unresectable, locally advanced or metastatic * At least one uni-dimensional measurable lesion by RECIST criteria * Age 18 to 75 years old * Estimated life expectancy ≥3 months * ECOG performance status ≤2 * Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL) * Adequate kidney function (creatinine \< 1.5 mg/dL) * Adequate liver function (bilirubin \< 2.0 mg/dL, transaminase levels \<2.5 times the upper normal limit) * Written informed consent Exclusion Criteria: * Other tumor type than adenocarcinoma * Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin) * Presence of CNS metastasis, psychosis, or seizure * Obvious bowel obstruction * Evidence of serious gastrointestinal bleeding * Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri * Pregnant or lactating women, women of childbearing potential not employing adequate contraception * Other serious illness or medical conditions
References
Publications (0)
Data not yet available
No reference posted for this study.