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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Japan Clinical Cancer Research Organization.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227239
First Posted: October 25, 2010
Last Update Posted: November 27, 2012
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.
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by:
Japan Clinical Cancer Research Organization
  Purpose

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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Cancer Research Organization:

Primary Outcome Measures:
  • 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

  • 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:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: September 2010
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01227239


Locations
Japan
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.
Investigators
Principal Investigator: Toshiaki Watanabe, M.D. Tokyo University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toshiaki Watanabe, Teikyo University
ClinicalTrials.gov Identifier: NCT01227239     History of Changes
Other Study ID Numbers: JACCRO CC-04
First Submitted: October 18, 2010
First Posted: October 25, 2010
Last Update Posted: November 27, 2012
Last Verified: November 2012

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