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  • Top Gear

    Acronym: 

    Top Gear

    ACTRN/NCT /ethics: 

    ACTRN12609000035224 NCT01924819

    Scientific title: 

    A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer

    Summary of trial and patient characteristics

    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase II, Phase III Tumour Stream Stomach
    Age Range 18 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2009-09-01
    Molecular Target Anticipated End Date 2020-12-01
    Cancer Type Stomach & Oesophageal
    Trial Type Treatment
    Phase Phase II, Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Stomach
    Cancer Stage All stages
    Anticipated Start Date 2009-09-01
    Anticipated End Date 2020-12-01

    Trial 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.

    Lay Summary

    A Randomised Phase II/III Trial of Preoperative Chemoradiotherapy Versus Preoperative Chemotherapy for Resectable Gastric Cancer

    Sponsor / Cooperative group

    Australasian Gastro-Intestinal Trails Group

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Chris Karapedis Recruiting