Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
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|ClinicalTrials.gov Identifier: NCT01227239|
Recruitment Status : Unknown
Verified November 2012 by Japan Clinical Cancer Research Organization.
Recruitment status was: Active, not recruiting
First Posted : October 25, 2010
Last Update Posted : November 27, 2012
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 .
|Condition or disease||Intervention/treatment||Phase|
|Rectal Carcinoma||Drug: S-1 Drug: Oxaliplatin Radiation: Radiation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2016|
40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.Drug: Oxaliplatin
40-60mg/m2/week intravenously on day 1, 8, 22 and 29.Radiation: Radiation
Total dose is 50.4Gy (1.8Gy X 28 fractions)
- 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.
- R0 resection rate [ Time Frame: 12-16 weeks ]
- down staging rate [ Time Frame: 12-16 weeks ]
- local reccurence rate [ Time Frame: 3 years ]
- desease free survuval [ Time Frame: 3 years ]
- safety [ Time Frame: 16-20 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227239
|Nagoya University Graduate School of Medicine|
|Nagoya, Japan, 466-8550|
|Osaka Medical College|
|Osaka, Japan, 569-8686|
|Jichi Medical University Hospital|
|Tochigi, Japan, 329-0498|
|Tokyo, Japan, 113-0033|
|Cancer Institute Hospital|
|Tokyo, Japan, 135-8550|
|Tokyo, Japan, 173-8606|
|Principal Investigator:||Toshiaki Watanabe, M.D.||Tokyo University|