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

Primary Purpose

Rectal Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
S-1
Oxaliplatin
Radiation
Sponsored by
Japan Clinical Cancer Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Carcinoma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya University Graduate School of Medicine
  • Osaka Medical College
  • Jichi Medical University Hospital
  • Tokyo University
  • Cancer Institute Hospital
  • Teikyo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Phase I: Determine the Recommended dose (RD)
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Phase II: pathological complete response rate
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
down staging rate
local reccurence rate
desease free survuval
safety

Full Information

First Posted
October 18, 2010
Last Updated
November 26, 2012
Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01227239
Brief Title
Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting
Official Title
A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Total dose is 50.4Gy (1.8Gy X 28 fractions)
Primary Outcome Measure Information:
Title
Phase I: Determine the Recommended dose (RD)
Description
Based on the incidence of dose-limited toxicities(DLT), the RD is determined from 4 test levels
Time Frame
10 weeks
Title
Phase II: pathological complete response rate
Description
Pathological complete response(pCR) rate is calculated by numbers of pCR cases (grade 3) devided the number of subjected cases.
Time Frame
12-16 week
Secondary Outcome Measure Information:
Title
R0 resection rate
Time Frame
12-16 weeks
Title
down staging rate
Time Frame
12-16 weeks
Title
local reccurence rate
Time Frame
3 years
Title
desease free survuval
Time Frame
3 years
Title
safety
Time Frame
16-20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN) Possible to R0 resection Received no prior therapy Performance status (ECOG) 0-1 Normal organ and marrow function. Sufficient oral intake Exclusion Criteria: History of serious allergic reaction Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool). Female with pregnancy or lactation Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Watanabe, M.D.
Organizational Affiliation
Tokyo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya University Graduate School of Medicine
City
Nagoya
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Osaka Medical College
City
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo University
City
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Facility Name
Cancer Institute Hospital
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Teikyo University
City
Tokyo
ZIP/Postal Code
173-8606
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25612635
Citation
Ishihara S, Matsusaka S, Kondo K, Horie H, Uehara K, Oguchi M, Murofushi K, Ueno M, Mizunuma N, Shinbo T, Kato D, Okuda J, Hashiguchi Y, Nakazawa M, Sunami E, Kawai K, Yamashita H, Okada T, Ishikawa Y, Nakajima T, Watanabe T. A phase I dose escalation study of oxaliplatin plus oral S-1 and pelvic radiation in patients with locally advanced rectal cancer (SHOGUN trial). Radiat Oncol. 2015 Jan 23;10:24. doi: 10.1186/s13014-015-0333-8.
Results Reference
derived

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

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