TYPE: International Research Study
STATUS: In recruitment
GCF CONTRIBUTION: $17,520

TOPGEAR is an international, multi-centre, randomised, phase II/phase III clinical trial which is investigating whether the addition of radiation treatment to chemotherapy before a patient’s surgery can improve outcomes such as pathological complete response rates and overall survival. More than 70 centres across New Zealand, Australia, Canada and Europe are participating in this research. All participants received chemotherapy and will be randomly allocated to one of two treatment groups:

• preoperative chemotherapy followed by postoperative chemotherapy

• OR preoperative chemo-radiation followed by postoperative chemotherapy

Participants were seen frequently while on treatment, at least 3 weekly while on chemotherapy or chemo-radiation.  Follow up will be every 3 months during year 1 and then every 6 months until 5 years.

Phase II

Phase II of the trial enrolled 120 participants before its completion. In early 2015, a planned analysis of data from these 120 participants was performed. This analysis confirmed that the trial treatment posed no concerns from a safety perspective and the study should continue. The interim phase II feasibility and safety results were published in the Annals of Surgical Oncology, these results showed that pre-operative chemoradiation is safe and feasible and does not adversely affect surgical morbidity. Click here to view the published article in its entirety.

Phase III

TOPGEAR has completed recruitment to the phase III component with a total of 574 patients taking part in total.  Auckland City Hospital, Christchurch Hospital, Dunedin Hospital and Waikato Hospital have taken part in and contributed to the TOPGEAR study in the phase II component. Thanks to the Gut Cancer Foundation supporters, Auckland City Hospital continued to recruit patients to the phase III part of the TOPGEAR trial and enrolled another 4 participants onto the study.  This continuation for phase III of the study in Auckland is generously supported by funding from the Gut Cancer Foundation (GCF) and a Research Project Grant from Genesis Oncology Trust, awarded to the Principal Investigator for Auckland City Hospital, Dr Maria Pearse.

With the trial recruitment now completed, investigators at the Australasian Gastro-Intestinal Trials Group have received additional funding to move into the findings stage. Clinicians will be able to hear an update on TOPGEAR when the trial is presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting in October.