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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PRECISE

TUMOUR: Gastro-Oesophageal

To determine the activity of pre- and post-operative chemoimmunotherapy compared with peri-operative chemotherapy plus post-operative immunotherapy in resectable distal oesophageal and gastro-oesophageal junction (GEJ) cancer and to validate putative biomarkers for immunotherapy benefit. Non-comparative randomised phase II trial.

 


NEEDS

TUMOUR: Oesophageal Cancer

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.

 


FOxTROT – 2/3

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.


STOPNET

TUMOUR: Neuroendocrine tumour

Neuroendocrine tumours are slow growing cancers, but they commonly spread around the body and do make patients more unwell as time goes on, usually years. Some neuroendocrine tumours produce hormones which cause a variety of symptoms. The main treatment for these tumours are somatostatin (a type of inhibitory hormone) injections. These injections slow tumour growth and reduce hormone production, hence relieve symptoms. Over time, the tumours continue to grow despite these injections, which is when an alternative treatment is given. This is called radionuclide therapy (a type of targeted radiotherapy). However, it is not known if continuing these somatostatin injections after this radiotherapy is worthwhile or not. These injections can cause side effects and are expensive for the healthcare system, so it is important to know.

In this project, to answer this question, we will stop these somatostatin injections in some patients. We will compare tumour growth rates, side effects and quality of life with patients in whom the injections are continued.


STING

TUMOUR: Gastric and Oesophageal cancer

DNA damage repair and the immune system are novel ways in which we are targeting cancer. Traditional anticancer treatment such as chemotherapy and radiotherapy induce DNA damage to destroy cancer cells. We have also been able to harness our immune system to attack cancer cells that have been able to evade detection from it until the advent of immunotherapy. The marker known as STING which detects leaked DNA fragments in our cells, an indicator the cell has been damaged, and instructs the cell to be destroyed. Stomach cancers express low levels of STING and it is thought that this may, in part, explain why they do not respond as well as we would like to traditional treatment.

Through this study, we are aiming to determine what impact STING levels have on the ability for cancer to respond to treatment, how this impacts the immune response to cancer and ultimately the ability to survive. This may also open up new therapies which enhance STING levels that can work hand in hand with our existing treatment to better improve outcomes in patients with stomach and oesophagus cancers.


POLARIS

TUMOUR: Rectal cancer

Rectal cancer is commonly treated by surgery and chemoradiotherapy. Surgery can often lead to low anterior resection syndrome (LARS) in some people. Standard treatment includes dietary modifications and medication. If these measures fail, more invasive treatments such as Transanal irrigation (TAI) (emptying the bowel by introducing water into the rectum) and Sacral nerve stimulation (SNS) (delivering electrical impulses through a wire to the nerve in the spine controlling the bowel) are trialled.

This study will investigate both SNS and TAI in patients with severe LARS symptoms against non-surgical management. The trial will investigate whether these treatments can improve patients’ symptoms, QoL and investigate the cost implications.

The study forms part of a collaborative initiative between United Kingdom (UK) and Australian centres. An identical study protocol will be run concurrently across both countries.

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