NCT01227239
Unknown
Phase 1
A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
Overview
- Phase
- Phase 1
- Intervention
- S-1
- Conditions
- Rectal Carcinoma
- Sponsor
- Japan Clinical Cancer Research Organization
- Enrollment
- 45
- Locations
- 6
- Primary Endpoint
- Phase I: Determine the Recommended dose (RD)
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.
The purpose of this study is as follows,
- In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
- In phase II, to evaluate the antitumor effect (pCR rate) and the safety .
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
- •Possible to R0 resection
- •Received no prior therapy
- •Performance status (ECOG) 0-1
- •Normal organ and marrow function.
- •Sufficient oral intake
Exclusion Criteria
- •History of serious allergic reaction
- •Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
- •Female with pregnancy or lactation
- •Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
Arms & Interventions
1
Intervention: S-1
1
Intervention: Oxaliplatin
1
Intervention: Radiation
Outcomes
Primary Outcomes
Phase I: Determine the Recommended dose (RD)
Time Frame: 10 weeks
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Phase II: pathological complete response rate
Time Frame: 12-16 week
Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
Secondary Outcomes
- R0 resection rate(12-16 weeks)
- down staging rate(12-16 weeks)
- local reccurence rate(3 years)
- desease free survuval(3 years)
- safety(16-20 weeks)
Study Sites (6)
Loading locations...
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