NCT01291407

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer. Patients will be treated with external beam radiation therapy in a standard manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. Patients will be assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.

Conditions

• Gastrointestinal Neoplasms
• Gastric Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2011-02-08
• Last updated: 2013-09-18

Locations

1 site across 1 country: China