NCT03973008

Adujvant CT+CRT vs Adujvant CT After D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma

Phase III, Randomized, Open-label Study of Adjuvant Chemotherapy Combined With Chemoradiotherapy Versus Adujvant Chemotherapy After Standard D2 Resection for Locally Advanced Proximal Gastric Adenocarcinoma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard D2 radical resection.

Detailed description

Because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation. As a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.

Conditions

• Gastric Adenocarcinoma

Interventions

Type	Name	Description
RADIATION	Adjuvant Chemoradiotherapy	DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
DRUG	Adjuvant Chemotherapy	Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days

Timeline

• Start date: 2019-03-11
• Primary completion: 2024-02-29
• Completion: 2025-05-31
• First posted: 2019-06-04
• Last updated: 2019-06-04

Locations

1 site across 1 country: China