Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

COMPOSE : A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Multiple<Br/>Treatment TypesTypeMultiple
Treatment Types

ThreePhase Three

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Multiple treatment types,Radiotherapy,Systemic therapy | Blood / Myeloma / Lymphoma,Bowel (colorectum),Brain and spinal cord,Breast,CUP,Female reproductive organs,Head and neck,Lung,Sarcoma,Skin,Stomach and upper gastrointestinal tract,Urinary systemNeuroendocrine tumours

Trial Overview Read MoreRead more

This phase III study is trying to understand how safe and effective radiation-based treatment (177Lu-Edotreotide PRRT) compared to best standard of care treatment in people with neuroendocrine tumours that originate in the stomach, intestines or pancreas. .
 

This trial is treating patients with neuroendocrine tumours of gastroenteric or pancreatic origin.

This is a systemic therapy and radiation therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin

Commercial Sponsor

ITM Solucin GmbH

Summary

To be eligible for this study you will have well-differentiated aggressive grade 2 or grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin. Eligible participants will be randomly allocated to either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive Peptide Receptor Radionuclide Therapy (PRRT). PRRT using 177Lu-edotreotide with a defined number of cycles will be administered. The Amino-Acid Solution to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution. In the Active Comparator Arm, participants will receive best standard of care treatment of the investigator's choice of either CAPTEM (Capecitabine-Temozolomide), Everolimus, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Monc C Co-Team Leads
PCCTU.MoncC@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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