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Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

Study acronym: TOPGEAR
StatusActive, Not Recruiting
PhasePhase 2/3
Started2009-09
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 6 times since 2013-08-15; most recent filed 2025-02-28. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-02-28
Amendment Study Status, Contacts/Locations v6
2022-03-21
Amendment RecruitingActive, Not Recruiting Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v5
2019-01-15
Amendment Study Status, Study Design, Arms and Interventions, Contacts/Locations v4
2016-07-12
Amendment Study Status v3
2016-01-03
Amendment Study Status v2
2015-06-24
Amendment Study Status, Contacts/Locations v1
2013-08-15
Original filing
Trial Details
NCT Number NCT01924819
Lead Sponsor Australasian Gastro-Intestinal Trials Group
Collaborators: National Health and Medical Research Council, Australia, Trans Tasman Radiation Oncology Group, European Organisation for Research and Treatment of Cancer - EORTC, NCIC Clinical Trials Group
Conditions Gastric Cancer
Enrollment 574 participants
Start Date 2009-09
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-04