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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Jun 2025

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At a glance

  • Drugs Lu-177 octreotide (Primary) ; Capecitabine; Everolimus; Fluorouracil; Folinic acid; Lysine hydrochloride/arginine; Oxaliplatin; Temozolomide
  • Indications Gastrointestinal cancer; Neuroendocrine tumours; Pancreatic cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms COMPOSE
  • Sponsors itm Group; ITM Solucin

Most Recent Events

  • 28 May 2025 Status changed from recruiting to active, no longer recruiting.
  • 31 Jul 2024 Planned number of patients changed from 202 to 250.
  • 05 Apr 2024 Planned End Date changed from 1 Sep 2026 to 1 Sep 2027.

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