Neoadjuvant Chemoradiotherapy vs. Chemotherapy With Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with DT45Gy/25f plus three cycles of XELOX therapy or neoadjuvant chemotherapy alone using XELOX regimen following D2 gastrectomy and adjuvant chemotherapy for 3 cycles. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: First Hospital of China Medical University; First People's Hospital of Hangzhou; Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial People's Hospital; Guangxi Medical University Cancer Center; Liaoning Cancer Hospital & Institute; The First Affiliated Hospital of Anhui Medical University; Tianjin Medical University Cancer Institute & Hospital; Zhejiang Cancer Hospital
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• informed consensus of the enrolled patients

• being able to receive oral drug

• from 18 to 75 years old

• proven to be primary adenocarcinoma of gastric cancer and pre-operative staging cT3N2/N3M0, cT4aN+M0, cT4bNanyM0,

• no prior other chemotherapy and/or radiation against the disease

• normal function of all other vital organs including heart,liver ,kidney and so on

• Eastern Cooperative Oncology Group performance status: 0~2

Exclusion Criteria:

• history of other malignancy

• allergic reaction to capecitabine or oxaliplatin

• enrolled in other clinical trials

• abnormal GI tract function

• dysfunction of other organs

• pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy

• other situations judged as not adaptive to the study by investigators