Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Australasian Gastro-Intestinal Trials Group
Collaborators:
European Organisation for Research and Treatment of Cancer - EORTC National Health and Medical Research Council, Australia NCIC Clinical Trials Group Trans Tasman Radiation Oncology Group Trans-Tasman Radiation Oncology Group (TROG)