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Professor Trevor Leong discusses TOPGEAR Trial at ECC, Vienna, 2015
Professor Trevor Leong discusses a randomised trial, TOPGEAR (Trial Of Pre-operative therapy for Gastric and Esophagogastric junction AdenocaRcinoma), which compares pre-operative chemoradiation with pre-operative chemotherapy alone for patients with resectable gastric cancer. The background of this study is that currently the optimal adjuvant strategy for patients with gastric cancer is unknown. In Western countries there are two standards of care. There is either post-operative chemoradiotherapy or peri-operative chemotherapy using epirubicin/cisplatin/fluorouracil (ECF).
Chemoradiation in the pre-operative phase: TOPGEAR trial
This trial compares chemoradiation to chemotherapy alone in the adjuvant setting but with the advantage of bringing the chemoradiation in the pre-operative setting which has a lot of advantages compared to post-operative treatment. TOPGEAR is split in two parts: Part 1 to show the feasibility and safety and Part 2 to examine the overall survival as primary endpoint. Part 1 is the phase II component and will recruit 120 patients, while Part 2 is the phase III component that will involve further 632 patients to provide a total sample size of 752 patients.
Hematological and non-hematological toxicities in phase II
Part 1 of the TOPGEAR trial was completed in 2015. The safety profile shows very similar hematological and non-hematological toxicities between the chemoradiation and the chemotherapy arm. The study demonstrates particularly that the strategy with chemoradiation in the pre-operative setting doesn’t affect surgical compliance and surgical complications compared to control.
TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG).
Leong T, Smithers BM, Michael M, Gebski V, Boussioutas A, Miller D, et al.BMC Cancer 2015 Jul 21;15:532.