drugset / Trial / NCT01815853
Neoadjuvant Chemoradiotherapy vs. Chemotherapy Followed by Radical Gastrectomy and Adjuvant Chemotherapy for Advanced Gastric Cancer
Phase 3
Completed
620 enrolled
Sun Yat-sen University
First Hospital of China Medical University · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangdong Provincial People's Hospital · collabLiaoning Cancer Hospital & Institute · collabNational Clinical Research Center for Cancer/Cancer Hospital · collabSichuan Cancer Hospital and Research Institute · collabThe Affiliated Hospital of Qingdao University · collabThe Affiliated Tumor Hospital of Guangxi Medical University · collabThe First Affiliated Hospital of Anhui Medical University · collabTianjin Medical University Cancer Institute and Hospital · collabZhejiang Cancer Hospital · collabZhejiang University · collab
RandomizedParallel-groupOpen-labelTreatment
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 3-year disease free survival (DFS), and secondary end point is 5-year overall survival (OS), R0 resection rate, pathological complete remission (pCR) and treatment safety.
Timeline
- Start
- 2013-06
- Primary completion
- 2025-06
- Completion
- 2025-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Oxaliplatin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |