Status:
UNKNOWN
Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
Lead Sponsor:
Japan Clinical Cancer Research Organization
Collaborating Sponsors:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Rectal Carcinoma
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01227239
Start Date
September 1 2010
End Date
August 1 2016
Last Update
November 27 2012
Active Locations (6)
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1
Nagoya University Graduate School of Medicine
Nagoya, Japan, 466-8550
2
Osaka Medical College
Osaka, Japan, 569-8686
3
Jichi Medical University Hospital
Tochigi, Japan, 329-0498
4
Tokyo University
Tokyo, Japan, 113-0033