A grant to fund the AGITG’s TOP GEAR trial for both phase II and phase III of the trial and initial follow up has been secured and international participation confirmed, making it one of the AGITG’s most significant trials to date.
TOP GEAR is a large scale randomised phase II and phase III trial that compares two different treatment regimens for resectable gastric cancer. This trial will determine future international standards for clinical practice.
An international, intergroup trial, TOP GEAR is led by the Australasian Gastro-Intestinal Trials Group (AGITG) and the NHMRC Clinical Trials Centre (CTC), in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), the European Organisation for Research and Treatment of Cancer (EORTC) and the NCIC Clinical Trials Group (NCIC CTG) in Canada.
Phase II is currently recruiting 120 patients to assess the safety and feasibility, and Phase III will recruit an additional 632 patients (total sample size 752) to assess overall survival.
“Having secured funding for their participation, our international partners EORTC and NCIC CTG are now involved in Phase 2 and they hope to recruit their first patients in early 2013. Here in Australia we have just recruited our 61st patient, which means we are half way through our recruitment target for phase II,” said Danielle Miller, TOP GEAR Program Manager.
“This is one of the first times the AGITG has a led a trial of this magnitude and it is exciting to part of a trial which has the potential to change clinical practise worldwide,” she concluded.
“We always knew that this trial was an ambitious project that required international collaboration and lots of money to succeed. It is very exciting that we now have both, and is testament to the importance of the trial internationally. Now we need the patients!” said Principal Investigator A/ Prof Trevor Leong.
For more information about TOP GEAR click here.