April 2020: AGITG Trial Updates

DYNAMIC-Pancreas

DYNAMIC-Pancreas is one of three AGITG trials investigating ctDNA analysis, an emerging area in GI oncology that shows promise. DYNAMIC-III and DYNAMIC-Rectal studies are also open, investigating ctDNA-informed adjuvant therapy strategies in colon and rectal cancer respectively.

DYNAMIC-Pancreas aims to demonstrate that a ctDNA-informed adjuvant therapy approach following curative intent surgery for localised pancreatic cancer could reduce the proportion of patients that have detectable ctDNA after completing therapy, compared to the standard of care treatment.

Previous ctDNA studies have found that the percentage of patients with detectable levels of ctDNA in their blood correlated with the stage of cancer, and that the concentration of ctDNA in blood increased as the cancer stage increased. The DYNAMIC studies will extend this knowledge by determining whether ctDNA can be used to inform decisions around therapy for patients by predicting the likelihood of relapse following surgery.

“I hope that ctDNA analysis will enable us to more accurately define recurrence risk and allow us to adjust treatment according to the individual patients’ risk of relapse,” says Dr Belinda Lee, Principal Investigator of the trial.

Pancreatic cancer has a high rate of relapse after surgery, which contributes to the low survival rate of this cancer. By understanding and grouping pancreatic cancer patients based on risk of recurrence and utilising a biomarker such as ctDNA, it may be possible to determine which patients are at greater risk of disease recurrence and escalate their chemotherapy to more intensive therapy accordingly.

Twenty patients have been enrolled in DYNAMIC-Pancreas out of a target of 438 at participating sites across Australia.

 

TOPGEAR

The purpose of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting in patients with resectable gastric cancer.

TOPGEAR is an international trial involving 66 sites in 15 countries across Australasia, Europe and Canada. It is an intergroup trial being conducted as a collaboration between the AGITG, TROG (Trans-Tasman Radiation Oncology Group), EORTC (European Organisation for Research and Treatment of Cancer), and the CCTG (Canadian Cancer Trials Group).

“The trial is in the final stages of recruitment and with over 500 patients recruited, it is already the largest trial evaluating preoperative chemoradiation for gastric cancer,” says Prof Leong. “TOPGEAR continues to generate considerable interest at international meetings and the results are eagerly awaited by clinicians worldwide.”

International clinical trials are a vital method of conducting research into diseases that affect patients worldwide. This means that new therapies can be made available to patients around the world at the same time, and this trial has the potential to change practice on a global scale.

Globally, 538 patients have joined the study out of a target of 570.

 

MONARCC

Metastatic colorectal cancer (mCRC) is a disease of the elderly, and anti-EGFR antibodies have not been well studied in this population. Therefore MONARCC aims to investigate the activity of panitumumab (monotherapy or combined with “light” chemotherapy, fluorouracil) in the first line setting, in molecularly selected patients over the age of 70 years.

Patients with RAS and BRAF wild-type mCRC can consent to participate in MONARCC providing they have not had prior treatment for their metastatic disease.

Dr Matthew Burge, Study Chair, believes that this regimen has the ability to be tolerated better thereby improving the patient’s quality of life and survival outcomes.

MONARCC is currently open at 19 sites in five states across Australia. As of 18 February, 16 patients have been enrolled in the study. MONARCC is one of the many AGITG trials that offer Australians living in rural, regional and remote areas an opportunity to patriciate in a clinical trial via the teletrial model. North Lakes Day Hospital, Hervey Bay Hospital and Townsville Hospital are active satellite sites of Royal Brisbane and Women’s Hospital, with two patients enrolled into the study. This initiative will enable access to a larger, eligible patient population and community access to this much needed study.

Find more information on Teletrials here.

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