NCT02648841

A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 588 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
RADIATION	Adjuvant Concurrent Chemo-radiotherapy	Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral.
DRUG	Adjuvant chemotherapy for active comparator group	8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
DRUG	Adjuvant chemotherapy for experimental group	6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-06-01
• Completion: 2022-06-01
• First posted: 2016-01-07
• Last updated: 2016-01-07

Locations

1 site across 1 country: China