November 2019: Trial Updates

First site opens for MASTERPLAN

The MASTERPLAN trial for pancreatic cancer patients has opened its first site at Princess Alexandra Hospital, Queensland, led by AGITG Upper GI Working Party Member and Radiation Oncologist, Dr Dominique Lee.

MASTERPLAN is a randomised, phase II study of mFOLFIRINOX with and without stereotactic radiotherapy (SBRT) for pancreatic cancer patients with high risk and locally advanced disease. It aims to determine if adding SBRT to chemotherapy will improve locoregional control for patients with high-risk, borderline resectable, locally advanced pancreas cancer.

Approximately half of all pancreatic cancer patients experience locoregional recurrence. Even with surgery, 40% of patients will experience a localised regional recurrence in the first 12 months.

SBRT allows a significant dose escalation compared to standard external beam radiotherapy (EBRT) without an increase in toxicity. This is anticipated to increase the number of tumour cells killed and reduce rates of locoregional recurrence.

“There is a desperate need for improved treatment for patients with pancreatic cancer,” says Dr Andrew Oar, the Study Chair. “We hope that this study investigating the combination of cutting edge radiotherapy with highly active chemotherapy will significantly improve patient outcomes in this devastating disease.”

The study aims to recruit 120 patients across Australia with more sites expected to open soon.

More information about MASTERPLAN is available here.


Using monotherapy with MONARCC

A clinical trial treating elderly people with metastatic colorectal cancer (mCRC) with panitumumab alone or in combination with chemotherapy (5-fluorouracil plus leucovorin (5FU + LV)) is currently recruiting participants around Australia. The MONARCC clinical trial is investigating the activity of these treatments in people aged 70 years and older for their effects on cancer growth and treatment side effects. Only patients with RAS and BRAF wild-type cancer are selected to participate due to their level of sensitivity to panitumumab.

Panitumumab (“anti-EGFR” treatment) is a biological treatment that targets a protein called epidermal growth factor receptor (EGFR) found on the surface of certain types of cancer and encourages its growth. Panitumumab needs further research in this older population who may not be suited to have the full chemotherapy regimen administered along with this treatment.

The Australian Therapeutics Goods Administration approved panitumumab for treating patients with metastatic CRC who failed prior chemotherapy. There are however misconceptions that survival is shortened with monotherapy, and that to maximise the benefits from chemotherapy or targeted therapy, combination therapy is required, at least initially.

“Trials conducted in metastatic CRC that have compared monotherapy with combination therapy show that response rates and time to cancer regrowing tend to be lower with monotherapy without compromising overall survival,” says Dr Matt Burge, Principal Investigator of MONARCC.

“Using agents in a sequential manner can be a good option for patients as it results in the same survival time and is often a better tolerated strategy.”

The research team is exploring regional sites that may wish to participate as a satellite site or via the tele-trial model.

More information on MONARCC is available here.

First patient joins PALEO

First patient joins PALEO

The first participant has joined the phase II PALEO trial, which is investigating palliative oesophageal cancer chemoradioimmunotherapy.

The PALEO team, led by Dr Fiona Day, is studying the effects of nivolumab and SBRT added to chemoradiotherapy in metastatic oesophageal cancer. It aims to prolong relief from dysphagia (difficulty swallowing) for patients undergoing palliative treatment for oesophageal or gastro-oesophageal cancer.

“PALEO offers multimodality treatment to address the complications of oesophageal cancer,” says Dr Day. “Each of the treatment components is typically well tolerated, which fits our aim of optimising patient quality of life by aiding return to a normal diet with minimal side effects. The feasibility of this approach is demonstrated by recruitment of our first patient shortly after trial opening.”

Typically, patients with oesophageal cancer present with dysphagia. Dr Day and Prof Martin found that first line concurrent chemoradiotherapy with low dose weekly carboplatin and paclitaxel resulted in all 18/ patients in a phase I study achieving improvement in their dysphagia. The majority of patients also returned to a normal diet, and at least three achieved complete relief of their dysphagia for over a year.

In the PALEO study, researchers aim to prolong this dysphagia relief and simultaneously  provide distant disease control with the use of immunotherapy and SBRT to a metastatic site.

PALEO is open in Calvary Mater Newcastle and recruiting patients with oligometastatic oesophageal or gastro-oesophageal cancer. It is the first trial to be activated under the AGITG Endorsed Study Model.

Find out more about PALEO here.


Recent sites activated

The following sites have opened for AGITG trials in the past month:

DYNAMIC-Rectal Peninsula Health
DYNAMIC-Pancreas Southern Medical Day Care Centre
INTEGRATE II Kangbuk Samsung Hospital, Korea