The first Japanese site in an AGITG trial opens for INTEGRATE II

The first AGITG trial site in Japan has opened for the INTEGRATE II study in gastro-oesophageal cancer.

National Cancer Centre Hospital East led by Dr Shitara officially opened on 7 February and recruited its first patient on 4 March. Subsequently, two more patients have been enrolled, and two additional Japanese sites have opened.

This is a significant milestone that came after two years of negotiations. The AGITG and the Clinical Trials Centre (CTC) had never run trials in Japan before. Discussions began in January 2016 between the AGITG and Syneos Health around developing an operating model in Japan.

Eric Tsobanis, the Project Manager for INTEGRATE II, says this is a landmark achievement for the CTC and AGITG, “Given neither have run trials in Japan previously, and due to the complexity of setting up a study in that country and adapting to business practices and culture different to ours.”

During the negotiation period, the treatment landscape for gastric cancer changed. Standard treatments existed up to fourth line therapy for gastric cancer in Japan. This led the AGITG to amend the INTEGRATE II protocol to allow the recruitment of Japanese patients in the fifth line.

Tsobanis says that achieving this milestone “Represents the establishment of a significant collaborative relationship with Japanese Investigators and hopefully the first of many collaborations on future trials.”

INTEGRATE II is a phase III clinical trial to determine if Regorafenib is an effective new treatment option for patients with advanced gastro-oesophageal cancer.

Watch the recruitment video with Principal Investigator A/Prof Nick Pavlakis: