drugset / Trial / NCT03013010

PREACT Study: Locally Advanced Gastric Cancer, Chemoradiotherapy vs. Chemotherapy Followed by D2 Surgery and Adjuvant Chemotherapy

NCT03013010

RandomizedParallel-groupOpen-labelTreatment

Summary

Although the incidence of gastric cancer has been substantially declining for several decades, it is still the sixth most common cancer and the fourth most frequent cause of cancer death worldwide. Surgery is still the only curative option for gastric cancer. However, most patients are unable to undergo surgery because of late stage, unresectable disease. The prognosis for these patients is very poor. Although the Magic trial showed that perioperative chemotherapy can increase the rate of curative surgery and significantly improve overall survival in patients with operable gastric or lower esophageal adenocarcinomas, no pCR events were reported in this trial. The intervention arm in PREACT consists of pre-operative chemotherapy, pre-operative radiochemotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery, and post-operative chemotherapy. The primary purpose of PREACT is to investigate whether the addition of radiochemotherapy to chemotherapy is superior to chemotherapy alone in the pre-operative setting in improving disease free survival in patients with locally advanced gastric or esophagogastric junction adenocarcinoma.

Timeline

Start
2016-12
Primary completion
2024-12-05
Completion
2024-12-05

Drugs

EvaluationDrugModalityDoseRoute
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background S-1 Small molecule 40 mg/m2 Oral
Background S-1 Small molecule 60 mg/m2 Oral
Background S-1 Small molecule 80 mg Oral
Background S-1 Small molecule 100 mg Oral
Background S-1 Small molecule 120 mg Oral