July 2019: AGITG trial updates

Click here to view the recruitment status of all open AGITG trials.

RoLaCaRT: Could using robots lead to more successful surgeries?

Using a robot rather than keyhole surgery could lead to a higher rate of successful surgeries for people with colon cancer.

The RoLaCaRT trial will recruit over 300 people with right-sided colon cancer. Almost half of cancer cases develop in the right-hand side of the colon, and these have lower survival rates than left-sided colon cancer.

Surgery for these cases of colon cancer was traditionally performed through open surgery, but laparoscopy (keyhole surgery) has been proven to have the same long-term survival outcomes as well as several advantages for the patient. These include shorter length of stay, less pain, early return of bowel function, early return to work, and less scarring and chance of hernias in the long term.

Professor Andrew Stevenson, Principal Investigator of the trial, believes that robotic surgery could improve these outcomes yet again.

“For the past seventeen years, robotic surgery has largely been one for treatment of prostate cancer,” he says. “Newer versions of the robot are allowing us to do more complex operations involving the bowel.”

This will be the first trial of its kind in the world. To accurately determine the benefits of robotic surgery compared to laparoscopy, Professor Stevenson and his team are using a new term, ‘successful surgery’. This will measure the number of patients who have surgery with no complications and are release from hospital quickly their cancer entirely removed.

“What we’re mainly looking at is the number of times that patients will have successful surgery if it’s done robotically compared to laparoscopically,” says Professor Stevenson. “We suspect that there may be a 15-20% difference between those two groups.”

One key factor that the trial will shine light on is whether the robots, which cost around $4 million, provide a benefit to patients. If there are found to be fewer complications or better outcomes for patients with robotic surgery, than this cost would be worthwhile.

The surgical operation performed for many patients with this type of colon cancer is a right hemicolectomy. Around 8,000 right hemicolectomies are performed each year.

“It’s important that the surgery – which is still the main way of treating colon cancer, to remove it – is as good as can be performed,” says Professor Stevenson.


Amendments made to DYNAMIC-Pancreas

Amendments have been made to the DYNAMIC-Pancreas trial, which will allow clinician discretion in the choice of chemotherapy they prescribe their patients.

The primary aim of DYNAMIC-Pancreas is to demonstrate that risk-stratified treatment using circulating tumour DNA (ctDNA)-informed management following curative-intent surgery for localised pancreatic cancer can provide a more tailored approach to the patient and maintain outcomes.

The amendments to the study mean that clinicians can choose either gemcitabine with capecitabine or gemcitabine with Abraxane in cohorts B and C1 (outlined in the schema below).

As of 14 July 2019, seven patients have been enrolled onto the study and 13 sites activated. Local governance approvals are in progress at a further several sites across Australia. The study target is to recruit 438 patients over a period of 54 months. The study is being led by Principal Investigator Dr Belinda Lee.

DYNAMIC-Pancreas is the first large scale randomised clinical trial in pancreatic cancer that will investigate the utility of ctDNA to detect the presence of residual cancer cells following curative intent surgery and guide adjuvant chemotherapy management.

“I hope that liquid biopsies will become a routine aspect of clinical management enabling earlier detection of pancreatic cancer and detection of minimal residual disease following surgery,” says Dr Lee, “As well as enabling earlier detection of pancreatic cancer, detection of minimal residual disease following surgery and matching patients to the right treatment through their pancreatic cancer journey.”

For more information on DYNAMIC-Pancreas, email DYNAMIC-P@mh.org.au

Interim analysis completed for DYNAMIC-III

The DYNAMIC-III study is continuing as planned after the interim analysis resulted in no concerns being raised.

As of 18 June, 26 out of 34 sites have been activated. The first participant from Christchurch Hospital has been recruited, making DYNAMIC-III officially an international study. So far 211 participants have been recruited out of a target of 1,000, with Western Health the site that has recruited the most participants.

DYNAMIC-III aims to determine that a chemotherapy decision based on the presence or absence of circulating tumour DNA after surgery for stage III colorectal cancer will be more effective than standard of care treatment.

In the adjuvant setting, post-operative circulating tumour DNA (ctDNA) has been shown to be a marker of minimal residual disease, with the presence of ctDNA predicting recurrence in separate series of stage II colon cancers and locally advanced rectal cancers.

Participants with stage III colon cancer are eligible to join the trail, with an endpoint of three-year recurrence-free survival.