Clinical Trials

An expert in bowel cancer

Associate Professor Eva Segelov, Clinical Academic at the St Vincent’s Clinical School at UNSW and Medical Oncologist, shares some insights into her work in colorectal cancer and the AGITG Preceptorship in Colorectal Cancer

One of the many callings that Associate Professor Eva Segelov has is in mentoring the successors of her field. She is putting this into action by convening a two-day Preceptorship in Colorectal Cancer in August this year.

To be held over two days this August in Melbourne, the Preceptorship is the first of its kind to be held by the Australasian Gastro-Intestinal Trials Group (AGITG).

“It’s modeled on the Harvard short course format,” Segelov explained. “It will be restricted to 40 participants with five mentors who are key opinion leaders in colorectal cancer.”

The Preceptorship is aimed at medical and radiation oncology registrars as well as junior consultants. It will involve open discussions based around seminal papers on clinical research in colorectal cancer that participants nominate to present, with guidance from their mentor.

“Participants must apply to attend, stating why they want to come and what their learning objectives are,” said Segelov. “The aim is to look at how clinical trials have influenced the outcomes of colorectal cancer because all our advances have come through clinical trials.”

Segelov emphasised that the Preceptorship will also provide the learning environment that facilitates trainees and less experienced clinicians to say ‘I don’t understand’ and ask questions that they may not feel comfortable asking in a formal meeting.

“Ideally participants will come through the Preceptorship with a better ability to become involved in trials and manage patients as well as a greater understanding of where clinical trials fit — why high quality research is so important and why it is so important ask clinically meaningful questions,” she added.

Conducting clinical trials

Acknowledged as a leader in the diagnosis and management of gastrointestinal cancers, Segelov has played a key role as Australian Principal Investigator (PI) on a number of international studies run by the AGITG. These include the QUASAR2 and SCOT trials, two multicenter international studies that assessed additional treatment options for patients with colorectal cancer.

Through AGITG Segelov is the international PI is the ICECREAM trial in metastatic CRC. Defining the genetic profiles of patients’ tumours is an avenue that researchers are pursuing in the hope of ‘personalising’ cancer treatment- giving treatment to those likely to benefit and avoiding it in patients where it is unlikely to work.. One of the aims of the ICECREAM trial is to clarify whether the rare subgroup of patients with the KRAS G13D mutation in their tumours respond to cetuximab. This is based on preclinical modelling as well as retrospective analyses of a number of previous clinical trials.

“The model of this trial is a little bit new for AGITG because we need to have clinicians across Australia actively referring patients to trial centres,” said Segelov. “We are reliant on referrals because the mutation is rare and one investigator is not going to see enough of these patients.”

People with KRAS mutations in their tumours cannot currently access cetuximab, and only the subgroup with this particular G13D mutation are eligible, ‘because that’s where the evidence points to’.

Almost all the sites for the ICECREAM trial have opened, including the international sites and recruitment is going well.

“The exciting thing about ICECREAM is that we (my co-PI Jeremy Shapiro, a very experienced AGITG clinical triallist and I) wrote the protocol, obtained the funding and have collaborated with world leaders in the field through interactions at the AGITG Annual Scientific Meetings , Segelov said, adding that she is proud to be leading an academic international study for which AGITG is the lead trials group.

Segelov chairs the Medical Oncology Committee for the 2013 AGITG Annual Scientific Meeting, for which the program is almost finalised. “The dinner should be a highlight again this year,” she laughed, “It will be the Gutsy Challenge and will involve physical, mental, singing, agility and eating challenges.”

Fundraising for GI cancer

Last year Eva was a member of the GI Cancer Institute’s City2Surf team— a 14 kilometre run through Sydney from Hyde Park to Bondi Beach.

“I’d never done it before, I didn’t train, I thought I’d walk it but we got pushed up early and I ended up running the whole way,” she recalled. “I was in so much pain the next day but it was good fun.”

She plans to do it again this year and is keen to see the money raised going towards clinical trials. Segelov is hopeful that members of the community will join her and the 2013 ‘Gutsy are Us’ City2Surf team for the GI Cancer Institute and noted that Nicky Lancaster (nicky@gicancer.org.au) at the GI Cancer Institute is coordinating the team.

“At the moment, we don’t have any independent source of funding for trials and the process of obtaining trial funding through granting bodies is way too slow,” she said.

As a member of the Lower Gastro-intestinal Working Party, one of two subgroups of the AGITG that serves as the first port of call for new protocols or trials people want to develop, Segelov is aware of a number of new concepts in the pipeline for colorectal cancer. Funding the early stages of these trials is challenging.

“We would like to have some significant fundraising so that we can start trials or at least get initial data through pilot studies without waiting for government grants, which are difficult to source for early stage work,” she said.

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