Overview

This trial is active, not recruiting.

Condition rectal carcinoma
Treatments s-1, oxaliplatin, radiation
Phase phase 1/phase 2
Sponsor Japan Clinical Cancer Research Organization
Collaborator Taiho Pharmaceutical Co., Ltd.
Start date September 2010
End date August 2013
Trial size 45 participants
Trial identifier NCT01227239, JACCRO CC-04

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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
s-1
40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
oxaliplatin
40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
radiation
Total dose is 50.4Gy (1.8Gy X 28 fractions)

Primary Outcomes

Measure
Phase I: Determine the Recommended dose (RD)
time frame: 10 weeks
Phase II: pathological complete response rate
time frame: 12-16 week

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: 1. Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN) 2. Possible to R0 resection 3. Received no prior therapy 4. Performance status (ECOG) 0-1 5. Normal organ and marrow function. 6. Sufficient oral intake Exclusion Criteria: 1. History of serious allergic reaction 2. Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool). 3. Female with pregnancy or lactation 4. Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment

Additional Information

Official title A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
Principal investigator Toshiaki Watanabe, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Japan Clinical Cancer Research Organization.