Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study)
Phase 1
Recruiting
- Conditions
- gastric cancer with peritoneal metastasis
- Registration Number
- JPRN-UMIN000030909
- Lead Sponsor
- Wakayama Medical University, School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Not provided
Exclusion Criteria
1. History of hypersensitivity to nab-paclitaxel, S-1, oxaliplatin 2. Contraindication to nab-paclitaxel, S-1, oxaliplatin 3. Infectious disease 4. HBs-antigen positive 5. Severe complication 6. Neuropathy with symptoms 7. Brain metastasis with clinical symptoms 8. Watery diarrhea. 9. Active double cancer 10. Persons to be pregnant or to make pregnant 11. Any subject judged by the investigator to be unfit for any reason to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: DLT Phase II: The rate of negative conversion in P1
- Secondary Outcome Measures
Name Time Method Phase 1: MTD, RD, adverse events, pharmacokinetics Phase 2: completion rate of treatment, response rate, curative resection rate, postoperative complication, pathological response rate, progression free survival, duration of disease control, recurrent free survival after gastrectomy, overall survival, time to treatment failure