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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
ITM Solucin GmbH
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).