Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

Summary

Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease (stage 1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%, a figure that has improved little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy. The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.

Timeline

Start

2009-09

Primary completion

2026-12-31

Completion

2026-12-31

Publications

• Leong T, Smithers BM, Michael M, Haustermans K, Wong R, Gebski V, O'Connell RL, Zalcberg J, Boussioutas A, Findlay M, Willis D, Moore A, Murray WK, Lordick F, O'Callaghan C, Swallow C, Darling G, Miller D, Strickland A, Liberman M, Mineur L, Simes J; Australasian Gastro-Intestinal Trials Group, National Health and Medical Research Council Clinical Trials Centre, Trans-Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer, and Canadian Cancer Trials Group. Preoperative Chemoradiotherapy for Resectable Gastric Cancer. N Engl J Med. 2024 Nov 14;391(19):1810-1821. doi: 10.1056/NEJMoa2405195. Epub 2024 Sep 14.

Drugs

Indications