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

NCT01227239 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-11-27

No results posted yet for this study

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 .

Conditions

  • Rectal Carcinoma

Interventions

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)

Sponsors & Collaborators

  • Taiho Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Japan Clinical Cancer Research Organization

    lead OTHER

Principal Investigators

  • Toshiaki Watanabe, M.D. · Tokyo University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-08-31
Completion
2016-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227239 on ClinicalTrials.gov