Clinical trial · Interventional
SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer
A Randomized Phase II Study of Oxaliplatin and S-1 (SOX) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Peritoneal Metastasis of Colorectal Cancer
NCT02870153CI-TRIAL-00023578unknownPhase 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 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of 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 |
|---|---|---|---|
| SOX | Drug | — | UNRESOLVED |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SOX(oxalipaltin+S-1)
- description
- 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: SOX
- type
- ACTIVE_COMPARATOR
- label
- XELOX (oxalipaltin+capecitabine)
- description
- 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
Primary outcomes (1)
- measure
- Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred Peritoneal metastasis of colorectal cancer At least one uni-dimensional measurable lesion by RECIST criteria Age 18 to 80 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 (4)
- BACKGROUNDBaratti D, Kusamura S, Pietrantonio F, Guaglio M, Niger M, Deraco M. Progress in treatments for colorectal cancer peritoneal metastases during the years 2010-2015. A systematic review. Crit Rev Oncol Hematol. 2016 Apr;100:209-22. doi: 10.1016/j.critrevonc.2016.01.017. Epub 2016 Jan 22. PMID 26867984
- BACKGROUNDEsquivel J. Colorectal cancer with peritoneal metastases: Progress, not perfection. J Surg Oncol. 2015 Jul;112(1):115. doi: 10.1002/jso.23954. Epub 2015 Jul 7. No abstract available. PMID 26153356
- BACKGROUNDOgawa M, Anan T, Suzuki T, Okuma M, Ichihara K, Hasegawa T, Yoshida K, Yanaga K. Initial Report of Phase II Study on Bi-weekly SOX plus Cetuximab Treatment for Wild-type K-RAS Advanced and Recurrent Colorectal Cancer. Anticancer Res. 2016 May;36(5):2505-11. PMID 27127165
- BACKGROUNDWang ZQ, Zhang DS, Xu N, Luo DY, Deng YH, Wang FH, Luo HY, Qiu MZ, Li YH, Xu RH. Phase II study of oxaliplatin combined with S-1 and leucovorin (SOL) for Chinese patients with metastatic colorectal cancer. Chin J Cancer. 2016 Jan 6;35:8. doi: 10.1186/s40880-015-0061-3. PMID 26739998