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A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer

NCT01291407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-09-18

No results posted yet for this study

Summary

The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.

Conditions

Interventions

DRUG

S-1

S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.

DRUG

S-1

S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.

DRUG

S-1

S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner

DRUG

S-1

S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.

DRUG

S-1

S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.

DRUG

S-1

S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jing Jin, MD,PhD · Department of Radiation Oncology,Cancer Hospital and Institute,CAMS

  • Yexiong Li, MD,PhD · Department of Radiation Oncology,Cancer Hospital and Institute, CAMS

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT01291407 on ClinicalTrials.gov