Peptide Receptor Radionuclide Therapy (PRRT)
COMPETE Phase III clinical trial
COMPETE is led as an international, prospective, randomized, controlled, open-label, multicenter phase III study. This means, that during the study new data will be collected (prospective), that results in patients receiving the new treatment are compared to a control group receiving the standard therapy (controlled) and that patients are randomly allocated to receive either n.c.a. Lutetium-177-Edotreotide or the current standard of care (randomized). Additionally, patients and physicians know what drug is being administered (open-label) and the study is conducted at multiple sites in multiple countries simultaneously (multicenter).
The trial will evaluate the efficacy and safety of the targeted radiopharmaceutical n.c.a. Lutetium-177-Edotreotide (PRRT) compared with the standard therapy Everolimus in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). It is intended specifically for patients who have progressive NETs which have spread to other parts of the body (metastatic) or that cannot be removed with surgery.
If you are interested in taking part in the study, please ask your attending clinician whether you comply with the inclusion criteria.
What Australian Sites are currently recruiting?
Austin Health, Centre for PET
Heidelberg VIC 3084, Australia
Principle Investigator: A/Prof Niall Tebbutt
Contact: (03) 9496 5000
Fiona Stanley Hospital
Murdoch / Perth WA 6150, Australia
Principle Investigator: Dr Andrew Kiberu
Contact: (08) 6152 2222
Peter MacCallum Cancer Centre
Melbourne VIC 3000, Australia
Principle Investigator: A/Prof Michael Michael
Contact: (03) 8559 5000
Royal North Shore Hospital
St Leonards / Sydney NSW 2065, Australia
Principle Investigator: A/Prof Nick Pavlakis
Contact: (02) 9926 7111
For more information about this trial, click below to download the patient friendly brochure:
Lutetium-177 OPS-201 for Progressive Metastatic Neuroendocrine Tumours
Official Title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
The purpose of this clinical phase I/II study is to investigate the safety and tolerability of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumours (NETs). Secondary objectives of this study are the assessment of biodistribution, dosimetry and preliminary efficacy of 177Lu-OPS201.
Contact for trial:
Theranostics Australia +618 9091 1081 or email email@example.com
For more information on this trial, please click here
Metastatic Liver NETs
A phase 1 Study to Assess the Safety, Tolerability and Effectiveness of PV-10 Chemoablation of Neuroendocrine Tumours (NET) Metastatic to the Liver (protocol PV-10-NET-01) is open for recruitment.
The purpose of this study is to assess the safety and effectiveness of PV-10 in treating patients with neuroendocrine tumours (NETs) that have metastasized (spread) to the liver that cannot be treated with standard therapies such as surgery. To assess effectiveness of this treatment, information will be collected to see if common symptoms associated with NETs (e.g flushing or diarrhoea) can be reduced and whether the chemicals secreted by NET tumours are similarly reduced. If you have a NET which has spread to the liver, ask your doctor if you may be eligible to participate.
Trial Contact: Prof Tim Price – The Queen Elizabeth Hospital
Further trial details click here
Merkel Cell Carcinoma (MCC)
Trial Name : Avelumab in Subjects With Merkel Cell Carcinoma (JAVELIN Merkel 200)
Official Title: A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma
Australian Sites Recruting:
VIC: Peter MacCallum Cancer Centre – Dr Sandhu
NSW: Royal North Shore Hospital – Dr Guminski
Port Macquarie Hospital – Dr Begbie QLD: PAH, Dr Atkinson
QLD: Saint John of God (Subiaco) – Dr van Hagen
For more information on this trial please click here
Neuroendocrine Carcinoma (NEC)
Title: A Randomised Phase II Study Of nab-paclitaxel In Combination With Carboplatin As First Line Treatment Of Gastrointestinal Neuroendocrine Carcinomas (NABNEC Study)
Scientific Title: A phase II study to establish if carboplatin and nab-paclitaxel combination is an effective and tolerable chemotherapy treatment for grade 3 advanced gastrointestinal Neuroendocrine Carcinomas.
The primary purpose of this trial is to evaluate the safety and efficacy of carboplatin plus nab-paclitaxel in comparison with carboplatin plus etoposide chemotherapy for the treatment of gastrointestinal neuroendocrine carcinomas (NECs).
Contact person for trial:
Dr Lorraine Chantrill
Australasian Gastro-Intestinal Trials Group
Locked Bag M250
Camperdown NSW 2050
For more information on this trial click here.
To watch a short video see below:
Mid Gut NETs (mNETS) and Pancreatic NETs (pNETs)
Title: CONTROL NETs – Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium177 NeuroEndocrine Tumors Study
The ultimate goal of CONTROL NETs is to improve outcomes for patients with advanced GI/2 NETs. The primary endpoint is progression free survival (PFS). Secondary endpoints include objective tumour response rate (OTRR), overall survival (OS,) safety, resource utilization and quality of life (QoL).
Contact person for trial:
CONTROL NETs Trial Coordinator
NHMRC Clinical Trials Centre The University of Sydney Locked Bag 77 Camperdown NSW 1450
p: +61 2 9562 5000
Click here for more information on CONTROL NETs
Gastroenteric and Pancreatic NETs (GEP-NET)
Title: Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
Summary: The purpose of the Phase III study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Contact person for trial:
Royal North Shore Hospital, NSW
Peter MacCallum Cancer Centre, VIC
For more information on this trial please click here.