March 2021: Research Update

First sites for INTEGRATE IIb to open soon

The INTEGRATE II trial has transitioned to a INTEGRATE IIb after the study was updated to incorporate a promising new treatment.

The purpose of INTEGRATE II was to determine whether regorafenib improved overall survival for people with advanced gastro-oesophageal cancer. INTEGRATE IIb will determine whether a combination of regorafenib and the immunotherapy treatment nivolumab is more effective than standard chemotherapy for these patients. The first sites for INTEGRATE IIb are set to open soon.

The trial is led by Associate Professor Nick Pavlakis. The trial is led by Associate Professor Nick Pavlakis. He is working with international researchers to conduct the study, which is open across Australia, New Zealand, Korea, Japan, Taiwan and North America and is soon to open in Europe.

“Extremely promising results have been seen in an early trial with regorafenib and nivolumab, so we will be testing this treatment combination in a larger randomised trial to give authors a better chance at having their loved ones survive their stomach cancer diagnosis and have better treatment options available for those diagnosed in the future,” Professor Pavlakis says.

“There have been some great medical advances using regorafenib and nivolumab so now we need to test this treatment combination on larger numbers to give families a better chance at having their loved ones survive their stomach cancer diagnosis and have better treatment options available for those diagnosed in the future.”

Learn more about INTEGRATE IIb here.

Trials closing to enrolment soon

These AGITG trials are close to reaching their enrolment targets:

TOPGEAR, an international, phase II/III trial investigating whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting in patients with resectable gastric cancer.

ASCOLT, a phase IV trial evaluating the safety and efficacy of adjuvant aspirin 200 mg versus placebo 200mg and to determine if it can improve disease-free survival and overall survival in patients with resected Dukes C or high-risk Dukes B colorectal cancer.

NABNEC, a randomised phase II trial of patients with grade 3 neuroendocrine carcinomas (NECs) aiming to determine the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with carboplatin plus etoposide.

FORECAST-1, a pilot study aiming to demonstrate the feasibility of utilising tumour organoids established from fresh tumour biopsies of mCRC for high throughput drug testing to guide clinical decision making.

View the full list of open trials here.

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