The Australasian Gastro-Intestinal Trials Group (AGITG) has forged strong links with a range of research organisations and cancer centres internationally.
AGITG designed and led international studies
ALT-GIST is a randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST). Developed in collaboration with the Scandinavian Sarcoma Group and coordinated in Europe by the European Organisation for Research and Treatment of Cancer.
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ICECREAM is a randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with KRAS WT metastatic CRC and patients harbouring a G13D mutation. The study is being conducted at sites across Australia and in the UK at Hammersmith Hospital, London and in Europe at Vall d’Hebron University Hospital, Barcelona, Spain; Oncologia Medica, Seconda UniversitÃ degli Studi di Napoli, Italy; and University Hospital Leuven, Campus Gasthuisberg, Belgium.
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INTEGRATE is a randomised Phase II Double-Blind Placebo-Controlled Study of regorafenib in Refractory Advanced Oesophago-Gastric Cancer (AOGC). Conducted at AGITG cancer centres across Australia and New Zealand and at centres in Korea and at centres in Canada coordinated by the National Cancer Institute of Canada Clinical Trials Group.
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TOP GEAR is a randomised phase II/III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer. The trial is being conducted at cancer centres across Australia and New Zealand and at centres in Europe coordinated by the European Organisation for Research and Treatment of Cancer and at centres in Canada coordinated by the National Cancer Institute of Canada Clinical Trials Group.
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International Trials with AGITG participation
The Eastern Cooperative Oncology Group (ECOG)
The ECOG is one of the largest clinical cancer research organisations in the United States, and conducts clinical trials in all types of adult cancers. The Group was established in 1955 to perform multicentre cancer clinical trials. The AGITG has contributed patients and resources from Australasia to trials that have had a major impact on the current standard of care.
Two of these trials include:
ECOG 2288: A prospectively randomised trial of lowdose Leucovorin + 5-fluorouracil, high-dose Leucovorin + 5-fluorouracil, levamisole + 5-fluorouracil, or lowdose Leucovorin + 5-fluorouracil + levamisole following curative resection in selected patients with Dukes’ B or C colon cancer. AGITG contributed to this high priority ECOG trial. The results of this trial have helped define the current standard of care for stage III colon cancer in Australia, New Zealand and the United States.
ECOG 1292: A combined modality treatment for metastatic colorectal carcinoma to the liver: surgical resection of hepatic metastases in combination with continuous infusion chemotherapy. The AGITG contributed 23% of patients in this trial. The trial has since been published in the Journal of Clinical Oncology.
The National Adjuvant Breast and Bowel Project (NSABP)
The NSABP is a clinical trials cooperative group that for over 50 years has designed and conducted clinical trials in breast cancer and bowel cancer.
The AGITG has conducted NSABP trials in bowel cancer in Australasia. An example of such a trial is the NSABP C07 trial, which aimed to assess standard chemotherapy with or without Oxaliplatin for stage II or III colon cancer. This study is one of the largest trials of adjuvant therapy for colon cancer involving the new generation of cytotoxic drugs.
European Study Group for Pancreatic Cancer (ESPAC)
The AGITG has worked in collaboration with ESPAC on a trial called ESPAC3, which aims to work out the best chemotherapy treatment to improve the survival rate in people with pancreatic cancer after surgery. This study follows on from the ESPAC1 trial, which established that chemotherapy with Fluorouracil improved survival at five years compared to no treatment. The Cancer Research UK funds the central coordination of ESPAC trials.
The European Organisation for Research and Treatment of Cancer (EORTC)
The EORTC aims to develop, conduct, coordinate and stimulate laboratory and clinical research in Europe to improve the management of cancer and related problems by increasing survival and patients’ quality of life. The organisation also promotes multidisciplinary cancer research in Europe and is linked to other leading biomedical research organisations around the world. The AGITG has been involved in a number of collaborative international trials run by the EORTC, including:
EORTC 62024: This is a randomised phase III trial which aims to determine whether imatinib mesylate for two years improves overall survival in patients with intermediate and high risk GIST tumours which have been completely removed at surgery. This trial is currently in follow-up and the AGITG contributed 81 patients to the trial.
SURGIST: is a randomised phase III study which will evaluate the role of surgery in patients with advanced GIST, who have been treated and are responding to imatinib. This study will determine whether interval removal or debulking of the tumour increases the duration of response to imatinib.
EORTC 40983: Trial of pre- and post-operative chemotherapy versus surgery alone for the treatment of liver metastases originating from colon cancer. The study, testing the impact of a new chemotherapy regimen on resectable liver metastases, will provide information about the benefit of “adjuvant” chemotherapy in this setting and whether it is safe to give before and after surgery. Final results were published in 2008.
PETACC 6: EORTC in association with other research collaborative groups in the Pan European Trial for Adjuvant treatment of Colon Cancer (PETACC) group are leading a randomised, phase III study which will investigate whether the addition of oxaliplatin (Eloxatin ®) to pre-operative 5-FU-based chemoradiotherapy and post-operative 5-FU chemotherapy improves disease-free survival in patients with potentially resectable rectal cancer. The AGITG recruited 127 patients.
Trans-Tasman Radiation Oncology Group (TROG)
The AGITG has worked collaboratively with the Trans-Tasman Radiation Oncology Group on studies requiring the joint expertise that both groups can provide.
IG 9401: This randomised phase III clinical trial was designed to determine if adding chemoradiotherapy to surgery helped people with cancer of the oesophagus. The trial was completed, and the results were published in 2005 in Lancet Oncology, showing that chemoradiotherapy was safe and reduced the growth of the tumours, but did not necessarily improve survival.
TROG 01.04: A randomised trial of pre-operative radiotherapy for stage T3 adenocarcinoma of rectum. The primary aim of this trial was to compare the efficacy of short and long course pre-operative radiotherapy, both of which are considered standardof-care for rectal cancer in different countries. The trial was closed to accrual in May 2006 after 326 patients had been accrued from 27 Australian and New Zealand centres. Early data was presented at ECCO-14 in September 2007. Follow-up continued until June 2009.
National Cancer Institute of Canada (NCIC) — Clinical Trials Group
The NCIC was formed in 1947 through a joint initiative of the Department of National Health and Welfare and the Canadian Cancer Society. The NCIC aims to undertake and support cancer research and related programs in Canada that will lead to the reduction of the incidence, morbidity and mortality from cancer. The AGITG has partnered the NCIC in a number of clinical trials including:
PA3: This randomised phase III trial evaluated whether the addition of erlotinib, a targeted agent to gemcitabine chemotherapy, improved survival in patients with advanced pancreatic cancer. This study, reported in the Journal of Clinical Oncology in 2007, was the first to demonstrate a significant improval in survival in advanced pancreatic cancer by adding any agent to gemcitabine.
CO.17: This randomised phase III trial tested the drug cetuximab, a targeted epidermal growth factor inhibitor, in patients with advanced bowel cancer who had been previously treated with multiple chemotherapy regimens. It was reported in the New England Journal of Medicine in 2007 and demonstrated that cetuximab treatment was associated with a significant improvement in overall and progression-free survival. The AGITG contributed very significantly to this trial, recruiting 252 patients in total.
CO.20 is a randomised phase III trial which will investigate whether the addition of brivanib (BMS-582664), a tyrosine kinase inhibitor to cetuximab improves overall survival in patients with previously treated advanced bowel cancer. It has been developed jointly by the NCIC and the AGITG and is a follow-on trial from the successful C0.17. The AGITG recruited 417 patients to the study.
Oncology Clinical Trials Office (OCTO)
The Oncology Clinical Trials Office (OCTO) is concerned with the practical application of high quality clinical research into innovative and effective therapies particularly in the field of gastro-intestinal cancers. OCTO is part of the Clinical Pharmacology Department of Oxford University. The AGITG has established a link with this group.
QUASAR 2 is a randomised phase III trial which is evaluating whether the addition of bevacizumab, an angiogenesis inhibitor to capecitabine chemotherapy, improves disease free and overall survival in stage III and high risk stage II colorectal cancer. The AGITG recruited 219 patients to the study.
Cancer Clinical Trials Unit, Scotland (CaCTUS)
The Cancer Clinical Trials Unit, Scotland (CaCTUS) was established in 2004 as a virtual cancer trials organisation, forming a partnership with extensive expertise in cancer research, particularly in the design and management of large phase III trials. This expertise spans multiple disease sites, multiple treatment modalities, and specialised trials such as those involving translational research, health economics and quality of life studies. The key partners are the Cancer Research UK Clinical Trials Unit in Glasgow, and the NHS Scotland Information Services Division (ISD) Cancer Clinical Trials Team in Edinburgh.
SCOT (Short Course Oncology Therapy) is a study of adjuvant chemotherapy in colorectal cancer. SCOT, a randomised phase III non-inferiority study, aims to chemotherapy is as effective at 24 weeks of treatment in patients with colorectal cancer. The AGITG recruited 213 patients to the study.
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) is an independent, not-for-profit French organisation established in 1997, to promote international cooperation with foreign physicians in the treatment of cancer services.
LAP07 is an international trial led by GERCOR to test whether a combination of chemotherapy and radiotherapy is better than chemotherapy alone in patients with localised but inoperable pancreatic cancer. It will also investigate the possible role of the newer antibody type drugs. Investigators will assess whether survival is improved with the addition of radiotherapy and the newer drugs. The AGITG
recruited 32 patients to the study.