NCT02301481

A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

A Prospective, Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Concomitant Boost Intensity-Modulated Radiotherapy With S-1 in Locally Advanced Gastric Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.

Conditions

• Stomach Neoplasms
• Neoadjuvant Therapy
• Chemoradiotherapy
• Chemotherapy

Interventions

Type	Name	Description
RADIATION	SIB-IMRT	45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor
DRUG	S-1	40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment
PROCEDURE	Surgery	Surgery, preferred D2 lymphadenectomy
DRUG	SOX	SOX (S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-12-01
• Completion: 2017-12-01
• First posted: 2014-11-26
• Last updated: 2019-10-16

Locations

1 site across 1 country: China