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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SSGXXII

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.


Neo-IMPACT

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.


CEND-1

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.


NEEDS

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.


RESOLUTE

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.


A Phase II Trial Evaluating EGFR Inhibition with HDAC Inhibition in Refractory Colorectal Cancer

TUMOUR: Colorectal Cancer

Advanced bowel cancer is a major health problem in Australia and  there is an increasing incidence of bowel cancer in younger adults. Bowel cancer that has spread to other organs (metastatic) is a generally incurable disease with limited survival times, typically measured in months. Therefore it is imperative that new treatments are developed, particularly as bowel cancer is largely resistant to immunotherapy which is showing promise in a large range of other cancer types.

This study tests a novel combination of drugs which have shown promise in several laboratory studies. Specifically it tests the combination a drug (an antibody protein called cetuximab) which inhibits one of the cancer cell’s growth pathways (called the MAPK pathway) with another drug (valproate) which amongst other effects can act to inhibit molecules termed histone de-acetylases inhibitor (HDAC inhibitors). Laboratory studies have shown that many different combinations of MAPK pathway inhibitors and HDAC inhibitors are effective in damaging cancer cells and that this combination is more effective at causing cell death.

Laboratory studies have shown that many different combinations of MAPK pathway inhibitors and HDAC inhibitors are effective in damaging cancer cells and that this combination is more effective at causing cell death.


CONTROL NETS TR

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.

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