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Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting

Sponsor
Japan Clinical Cancer Research Organization (Other)
Overall Status
Unknown status
CT.gov ID
NCT01227239
Collaborator
Taiho Pharmaceutical Co., Ltd. (Industry)
45
Enrollment
6
Locations
1
Arm
71
Duration (Months)
7.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Sep 1, 2010
Anticipated Primary Completion Date :
Aug 1, 2013
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: S-1
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)

Outcome Measures

Primary Outcome Measures

  1. Phase I: Determine the Recommended dose (RD) [10 weeks]

    Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels

  2. Phase II: pathological complete response rate [12-16 week]

    Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.

Secondary Outcome Measures

  1. R0 resection rate [12-16 weeks]

  2. down staging rate [12-16 weeks]

  3. local reccurence rate [3 years]

  4. desease free survuval [3 years]

  5. safety [16-20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Cancer Institute Hospital Tokyo Japan 135-8550
6 Teikyo University Tokyo Japan 173-8606

Sponsors and Collaborators

  • Japan Clinical Cancer Research Organization
  • Taiho Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Toshiaki Watanabe, M.D., Tokyo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01227239
Other Study ID Numbers:
  • JACCRO CC-04
First Posted:
Oct 25, 2010
Last Update Posted:
Nov 27, 2012
Last Verified:
Nov 1, 2012
Additional relevant MeSH terms:
Carcinoma
Rectal Neoplasms
Oxaliplatin

Study Results

No Results Posted as of Nov 27, 2012