Canadian Cancer Trials Group Bulletins


GA.1 (TROG 0808) Featured in International Innovation

Canadian Cancer Trials Group GA.1 (TROG 0808), also known as TOPGEAR, has been featured in International Innovation, a global resource providing insight and analysis on current scientific research trends.

Canadian Cancer Trials Group GA.1 (TROG 0808) is an international randomized controlled trial (RCT) assessing whether in patients with resectable gastric or gastroesophageal junction cancer, adding preoperative chemoradiation therapy (CRT) to a standard therapy improves survival in comparison with that standard therapy alone. An accepted standard therapy for these patients, and the control arm of this RCT, is pre-operative chemotherapy followed by surgical resection and post-operative chemotherapy or "CSC". Another standard therapy is surgery followed by concurrently administered chemoradiation or "CRT". The investigators believe adding CRT to CSC will improve survival in patients with gastric cancer and that there are advantages to adding CRT to CSC prior to surgery as opposed to postoperatively. In this RCT, control arm therapy of CSC will be compared with experimental arm therapy of preoperative CRT plus CSC.

Treatment details of control arm CSC include use of the epirubicin, cisplatin, 5-fluorouracil regimen. Experiment arm patients will receive this same therapy plus CRT consisting of radiation therapy 45 Gy in 25 fractions five days per week for five weeks + continuous infusional 5- fluorouracil 200 mg/m2/day, 7 days per week throughout the entire period of radiotherapy. The primary endpoint is overall survival. Secondary objectives evaluate disease control, pathological findings at surgery, quality of life and economic endpoints. Biospecimens will be obtained and translational research questions will be asked.

The trial uses an adaptive phase II-III design. Initially, a randomized phase II trial will enroll 120 patients. Endpoints of this trial phase are safety and feasibility of the experimental arm and a test for a signal of efficacy using a surrogate endpoint (pathologic complete response). Provided protocol-stated endpoints are met, the trial will continue accrual as a randomized phase III trial to a total of 752 patients in order to assess overall survival.

The article, beginning on page 31, can be viewed in full using this link ..., features Dr. Rebecca Wong, Canadian Chair of Canadian Cancer Trials Group GA.1, and Dr. Chris O'Callaghan, Senior Investigator for the Canadian Cancer Trials Group's Gastrointestinal Site Committee and the GA.1 trial. Drs Wong and O'Callaghan provide indepth analysis of the development of the trial, about the collaborations that are necessary to conduct it, and the purpose of the trial.

Currently, the trial is open and recruiting participants at 3 Canadian centres. Any centres and investigators interested in participating should contact Barbara Graham, Study Coordinator, at 613-533-6430 or