The DYNAMIC Studies
AGITG currently has three studies investigating ctDNA in gastro-intestinal cancers. The three trials will help determine which patients are at risk of recurrence and will aim to prevent unnecessary chemotherapy for those who are not at risk. The suite of ctDNA trials began in 2015, and can now tell if bowel cancer patients are at high or low risk. The AGITG trials will be critical in helping improve the quality of life of patients with stage III colon cancer, rectal and pancreas cancers. DYNAMIC III, DYNAMIC-Rectal and DYNAMIC-Pancreas are all currently open to recruitment.
DYNAMIC III uses ctDNA to examine the presence of cancer in the patients with stage III colon cancer. Patients are randomised 1:1 to be treated according to ctDNA results after surgical removal of their bowel cancer or per standard of care. For the ctDNA –informed group, patients with a positive test will be treated with stronger chemotherapy than routine treatment. Patients with a negative test result will have milder chemotherapy or a shorter duration of routine treatment.
The trial has a large recruitment goal of 1000 patients, and is the largest of the three AGITG DYNAMIC trials. There are currently 155 patients recruited with a recruitment period set for 4.5 years. The trial is expected to run for 6.5 years. DYNAMIC III is currently open to 23 sites with a further ten expecting to open soon. The trial has a planned interim analysis in May 2019, to examine the ctDNA result turn-around time and protocol compliance.
Chief Investigators Associate Professor Jeanne Tie and Professor Peter Gibbs are leading the trial. Professor Gibbs has said that although this technology will not have a significant impact on the survival of patients in the short term, it will help to secure safer and more comfortable screening.
“Overall in terms of survival, screening will deliver the biggest impact,” says Professor Gibbs. “Ultimately if you can detect cancer that would not otherwise have been found in time then the patient may have the opportunity to go on to have curative surgery.”
He has also noted that the results of the DYNAMIC-III trial will be imperative to securing government funding into future research. In the long term, this could lead to national screening programs.
DYNAMIC-Rectal investigates the presence of ctDNA in the bloodstreams of patients with locally advanced rectal cancer. DYNAMIC-Rectal has currently recruited 40 of the targeted 408 patients over a three year period, the first patient was recruited in July of 2018.
DYNAMIC-Rectal has recently opened new sites at Tamworth Hospital, Goulburn Valley Health, Mid North Cost Cancer Institute (Port Macquarie Base Hospital). The end-goal is for patients with locally advanced colorectal cancer to have ctDNA analysis incorporated into routine clinical practice, to guide treatment decisions.
Principal Investigator Jeanne Tie says, “We are hoping this helps avoid over-treatment of patients with unnecessary chemotherapy and identify those patients at high risk of recurrence who actually need chemotherapy treatment.”
Watch A/Prof Tie discuss the DYNAMIC studies:
DYNAMIC-Pancreas has recently recruited its first patient in 2019. Pancreatic cancer is an aggressive form of gastro-intestinal cancer, DYNAMIC-Pancreas uses ctDNA to identify the recurrence in patients with pancreatic cancer post surgery. Patients are randomised 1:1 into either a non-biomarker driven, standard of care adjuvant treatment arm (Cohort A) or a ctDNA informed biomarker driven arm (cohort B), where treatment will be determined by the ctDNA results after surgery.
Principal Investigator Dr Belinda Lee says, “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.”
The trial aims to recruit 438 patients over a 54 month period. The trial is currently active at the Peter MacCallum Cancer Centre, Royal Melbourne Hospital, Northern Hospital, SVH Melbourne, Western Health Hospital, Eastern Health (Boxhill Hospital), Cabrini Hospital, and Lake Macquarie Private Hospital, and will be activating at Frankston Hospital and Newcatle Private in May.