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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Taiho Pharmaceutical Co., Ltd.
Information provided by:
Japan Clinical Cancer Research Organization

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
Rectal Carcinoma Drug: S-1 Drug: Oxaliplatin Radiation: Radiation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2010
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

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)

Primary Outcome Measures :
  1. 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

  2. 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.

Secondary Outcome Measures :
  1. R0 resection rate [ Time Frame: 12-16 weeks ]
  2. down staging rate [ Time Frame: 12-16 weeks ]
  3. local reccurence rate [ Time Frame: 3 years ]
  4. desease free survuval [ Time Frame: 3 years ]
  5. safety [ Time Frame: 16-20 weeks ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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

Information from the National Library of Medicine

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 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 University
Tokyo, Japan, 113-0033
Cancer Institute Hospital
Tokyo, Japan, 135-8550
Teikyo University
Tokyo, Japan, 173-8606
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Taiho Pharmaceutical Co., Ltd.
Principal Investigator: Toshiaki Watanabe, M.D. Tokyo University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Toshiaki Watanabe, Teikyo University Identifier: NCT01227239     History of Changes
Other Study ID Numbers: JACCRO CC-04
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents