Endorsed Study Model
Since 1991, the AGITG has been developing and conducting practice-changing research in GI cancers. In 2019, the scope of our research was expanded with the launch of the Endorsed Study Model.
This Model supports the development of pilot trials sponsored and conducted by other institutions, with the aim of developing data to support large-scale AGITG-led studies.
Benefits of the Endorsed Study Model
The AGITG will liaise with the sponsoring institution to:
- Conduct feasibility to gauge interest from a wide network of potential sites to participate in the study;
- Advertise the study on the AGITG website;
- Promote the study to AGITG members;
- Invite presentations at the ASM; and
- CAP review and feedback: lay summary of concept and master Participant Information Sheet and Consent Form.
Current AGITG Endorsed Studies
- PALEO: Led by Dr Fiona Day – studying the effects of nivolumab and SBRT added to chemoradiotherapy in metastatic oesophageal cancer.
- RENO: Led by Prof Chris Karapetis – a prospective study of ‘Watch and Wait’ strategy in rectal cancer patients.
- NEO-CREATE: Led by Dr Amitesh Roy – assessing the safety of adding the immunotherapy drug avelumab to chemo-radiation before surgery in patients with cancers of the oesophagus or the gastro-oesophageal junction.
- ALT-TRACC: Led by Dr Vanessa Wong – determining the efficacy of alternating oxaliplatin and irinotecan doublet schedules versus continuous doublet chemotherapy in previously untreated metastatic colorectal cancer.
- LICPIC: Led by A/Prof Steven Smith – assessing if giving local anaesthetic, Lignocaine, into your bloodstream during surgery will improve part of your immune system after surgery for colorectal cancer.
- GENESCREEN 5-FU: Led by Prof Stephen Ackland – aims to identify patients who are deficient in an enzyme known as DPD, to allow for safer chemotherapy dosing decisions.
- EXERTION: Led by Dr Jasmine Yee – aims to develop an exercise intervention delivered during chemotherapy infusion for colon cancer.
“I anticipate that our study will guide clinical practice and I hope that findings will lead to a clinical meaningful improvement in patient outcomes. On behalf of all the investigators involved with the RENO study, I sincerely thank the AGITG.” – Prof Chris Karapetis, RENO Study Chair
The AGITG encourages investigators to submit concepts requiring ‘endorsement’ or ‘sponsorship’ for consideration. Investigators requesting AGITG endorsement of concepts must agree to the following governance framework:
- AGITG governance for endorsement:
- AGITG Working Party reviews and approves the scientific merit of the research proposal.
- AGITG Consumer Advisory Panel reviews and approves the relevance of the concept from a consumer perspective.
- AGITG reviews the site payments allocated to conduct the study.
- A Trial Management Committee (TMC) is appointed to maintain oversight.
- An AGITG Member is an Investigator on the study.
- Reporting study updates to AGITG:
- The Working Party and Scientific Advisory Committee may request study updates throughout study duration.
- TMC and Data and Safety Monitoring Committee meeting minutes will be shared with the AGITG.
- The Institution will prepare and submit monthly progress reports in alignment with current AGITG practice, using the AGITG reporting template.
- Trial newsletters circulated to participating sites will be shared with AGITG.
- If the pilot research develops a positive signal that warrants a larger-scale study, AGITG will have the expectation to review and act as Sponsor of the study.
- The Project Leader and AGITG will work together to source additional grant or industry funding.
- A Coordinating Centre selected by the AGITG will coordinate the large-scale study.
- AGITG will request access to the pilot study data for the purposes of developing a larger-scale study.
- AGITG will be acknowledged in all publications arising from the pilot study to reflect the support provided to the Project Leader.