NCT04062058

A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Jing Jin, M.D. · Unknown
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma

Conditions

• Gastric Cancer
• Neoadjuvant Therapy

Interventions

Type	Name	Description
RADIATION	SIB-IMRT	45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
DRUG	S-1	40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment
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)
PROCEDURE	Surgery	Surgery, preferred D2 lymphadenectomy

Timeline

• Start date: 2019-11-20
• Primary completion: 2022-09-21
• Completion: 2023-09-21
• First posted: 2019-08-20
• Last updated: 2022-01-24

Locations

1 site across 1 country: China