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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Taiho Pharmaceutical Co., Ltd.
Information provided by:
Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:
NCT01227239
First received: October 18, 2010
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
Drug Information available for: Oxaliplatin
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • down staging rate [ Time Frame: 12-16 weeks ] [ Designated as safety issue: No ]
  • local reccurence rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • desease free survuval [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • safety [ Time Frame: 16-20 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Teikyo University
Tokyo, Japan, 173-8606
Cancer Institute Hospital
Tokyo, Japan, 135-8550
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Toshiaki Watanabe, M.D. Tokyo University
  More Information

No publications provided

Responsible Party: Toshiaki Watanabe, Teikyo University
ClinicalTrials.gov Identifier: NCT01227239     History of Changes
Other Study ID Numbers: JACCRO CC-04
Study First Received: October 18, 2010
Last Updated: November 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013