Concepts in Development

The AGITG research development strategy and prioritisation framework outline the process by which concepts progress from embryonic ideas to funded trials. The concepts listed below have been identified as a research priority for AGITG by the Working Parties, Consumer Advisory Panel and Scientific Advisory Committee, and are currently seeking funds to commence the trial.

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TUMOUR: Gastro-Intestinal Stromal Tumour (GIST)

Three years of imatinib is considered the standard duration of post therapy for patients with operable high-risk GIST. Yet, many patients are still at a high risk of GIST recurrence after completion of three years of adjuvant imatinib, and might benefit from further adjuvant imatinib therapy. The aim of SSGXXII is to compare the effect of giving imatinib for 5 years against 3 years, in patients who have undergone surgery for GIST, with the intent to prevent the tumour from coming back. The trial will look at the effect of the efficacy and safety of 5 years of treatment compared to 3 years.


TUMOUR: Pancreatic Cancer

Pancreas cancer continues to be a challenging cancer to diagnose, with a 5-year survival rate of 8.9%. NEO-IMPACT is a pilot study to treat people with early stage pancreas cancer chemotherapy with immunotherapy before surgery. In the last 12 months, there have been several advances that indicate that the manipulation of the microbiome, the make-up of the individual’s gut bacteria, may be critical to the success of future research programs in pancreas cancer. Immunotherapy has been shown to be effective across multiple cancers but is yet to show effect in pancreas cancer.


TUMOUR: Pancreatic Cancer

Pancreatic cancer is the fourth most common cause of cancer death in Australia and it is critical to develop a new treatment for patients with pancreatic cancer who have limited life expectancy. Increasing body of research suggest that bacteria within human body may be responsible for the development and survival of pancreas cancer. There is an emerging idea that changing gut bacteria may improve the effects of chemotherapy.

The MASTERPLAN Microbiome study is a translational research substudy within the MASTERPLAN trial to collect serial bacterial samples from patients receiving chemotherapy as part of MASTERPLAN trial. The main goal is to describe how the gut bacteria will change before and after chemotherapy.


TUMOUR: Pancreatic Cancer

Patients with metastatic pancreatic ductal adenocarcinoma (PDAC) have poor outcomes. Nevertheless, in the past few years, the development of more effective doublet and triplet chemotherapy regimens have improved median survival to approximately 8.5-11 months. The purpose of the CEND-1 study is to determine if the addition of CEND-1 to first line gemcitabine and nab-paclitaxel has sufficient activity and safety in patients with untreated metastatic pancreatic ductal adenocarcinoma.


TUMOUR: Oesophageal Cancer

Currently oesophageal cancer is the 7th most common cancer and the 6th most common cause of cancer deaths worldwide. Most oesophageal cancers are diagnosed in advanced stages. Today, oesophageal squamous cell carcinoma (SCC) has dismal outcomes worldwide. On a population level only a minority of patients with locally advanced resectable stages survive five years. This study aims to optimise the treatment strategy for patients with oesophageal SCC towards better outcomes in terms of survival, preservation of quality of life and health-economics.

The NEEDS trial will assess whether one of the two tested treatment approaches should be preferred in the future as standard therapy for patients with oesophageal squamous cell carcinoma. The study compares neoadjuvant chemoradiotherapy followed by surgery with definitive chemoradiotherapy, using defined chemoradiotherapy options, with post treatment surveillance and surgery (as needed) to obtain local tumor control.


TUMOUR: Colorectal Cancer

Bowel cancer is the 2nd leading cause of cancer-related deaths in Australia and one of the leading causes of cancer deaths in individuals under the age of 50. For the majority of patients with advanced or metastatic bowel cancer (cancer that has spread beyond the bowel), standard treatment with systemic treatment (intravenous anti-cancer therapy) can prolong life expectancy, but can never eradicate the cancer and achieve cure. “Oligometastatic cancer” is a relatively recent term that describes a type of metastasis in which cancer cells from the original (primary) tumour travel through the body and form a small number of new tumours (metastatic tumours) in one or two other parts of the body.

The RESOLUTE clinical trial aims to investigate the value of adding local ablative treatment to standard systemic treatment including the impact on survival, compared to continued standard systemic  treatment only, in patients with oligometastatic bowel cancer.


TUMOUR: Colorectal Cancer

Colorectal cancer is a major cause of cancer related deaths for which there is an urgent need to develop new treatments. The drug valproate has been to treat epilepsy and mood disorders for over 50 years. We have found that valproate can profoundly increase the anti-tumour activity of a class of drugs known as EGFR inhibitors in laboratory models of colon cancer. We will now test the activity of this drug combination in a phase II clinical trial in patients with advanced colon cancer.


TUMOUR: Colorectal Cancer

Colon cancer incidence is strongly related to age with its highest incidence in older patients, with 44% of new cases are diagnosed in patients aged 75 or over. Older patients must have access to safe and effective treatments, managing cancer in older adults poses several significant challenges.

FOxTROT-2 aims to investigate whether a modified regime of 6 weeks of chemotherapy prior to surgery and post operation MDT decision regarding Adjuvant Chemotherapy, improves the Disease Free Surivival in older patients with patients with locally advanced operable colon cancer.


TUMOUR: Neuroendocrine Tumours (NETs)

Peptide Receptor Radionuclide Therapy (PRRT) is an effective treatment for neuroendocrine tumours (NETs). CONTROL NETs, an AGITG study in follow up, tested whether adding chemotherapy to PRRT will make it more effective, the results are currently demonstrating an encouraging increase in tumour shrinkage. Normally we know who can benefit from PRRT, because their NET tumours will light up on a special type of PET scan (Gallium68 PET). However, we don’t have a way of knowing which patients will benefit from adding chemotherapy to the PRRT. The most likely way of finding who will benefit from chemotherapy is testing for a gene called MGMT.

This substudy of the CONTROL NETs trial will investigate whether testing MGMT in several ways at the same time (‘multi-omic testing’), and combining the results of these tests, can predict who will benefit from adding chemotherapy to PRRT. If it works, we will be able to identify who needs to have chemotherapy with PRRT, and who can have PRRT on its own.