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A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)


Phase 1/Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Rectal Carcinoma

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Trial Information

A Phase I/II Study of S-1 and Oxaliplatin Combined With Radiation for Preoperative Locally Advanced Rectal Carcinoma. (SHOGUN Trial)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Determine the Recommended dose (RD)

Outcome Description:

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

Outcome Time Frame:

10 weeks

Safety Issue:

Yes

Principal Investigator

Toshiaki Watanabe, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tokyo University

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JACCRO CC-04

NCT ID:

NCT01227239

Start Date:

September 2010

Completion Date:

August 2016

Related Keywords:

  • Rectal Carcinoma
  • Carcinoma
  • Rectal Neoplasms

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