- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01227239
Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
November 26, 2012 updated by: Japan Clinical Cancer Research Organization
A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
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 .
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nagoya, Japan, 466-8550
- Nagoya University Graduate School of Medicine
-
Osaka, Japan, 569-8686
- Osaka Medical College
-
Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
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Tokyo, Japan, 113-0033
- Tokyo University
-
Tokyo, Japan, 135-8550
- Cancer Institute Hospital
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Tokyo, Japan, 173-8606
- Teikyo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
Total dose is 50.4Gy
(1.8Gy X 28 fractions)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 weeks
|
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.
|
12-16 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
R0 resection rate
Time Frame: 12-16 weeks
|
12-16 weeks
|
down staging rate
Time Frame: 12-16 weeks
|
12-16 weeks
|
local reccurence rate
Time Frame: 3 years
|
3 years
|
desease free survuval
Time Frame: 3 years
|
3 years
|
safety
Time Frame: 16-20 weeks
|
16-20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Toshiaki Watanabe, M.D., Tokyo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
August 1, 2013
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
October 18, 2010
First Submitted That Met QC Criteria
October 21, 2010
First Posted (Estimate)
October 25, 2010
Study Record Updates
Last Update Posted (Estimate)
November 27, 2012
Last Update Submitted That Met QC Criteria
November 26, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Carcinoma
- Rectal Neoplasms
- Antineoplastic Agents
- Oxaliplatin
Other Study ID Numbers
- JACCRO CC-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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