BMC cancer · 2025
PReCedeNT trial: Phase III randomized-controlled trial of Lutetium - 177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) plus Chemotherapy versus PRRT alone in FDG-avid, Well-differentiated Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
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Puranik Ameya D, Dev Indraja D, Yadav Sushil, Rangarajan Venkatesh, Agrawal Archi, Basu Sandip, Chaudhari Vikram A, Ramaswamy Anant, Ostwal Vikas, Bhandare Manish S, Shrikhande Shailesh V, Parghane Rahul V, Bhargava Prabhat, Bal Munita M, Yadav Subhash, Patkar Shraddha, Goel Mahesh, Purandare Nilendu C, Shah Sneha, Choudhury Sayak, Ghosh Suchismita, Venkatachalam Manikandan
Аннотация
BACKGROUND: Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the standard of care for well-differentiated metastatic or locally advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, tumor heterogeneity, particularly in FDG-avid tumors, can limit treatment effectiveness. The PReCedeNT trial aims to evaluate the efficacy of combining PRRT with capecitabine and temozolomide (CAPE-TEM) chemotherapy compared to PRRT alone in patients with FDG-avid, well-differentiated GEP-NETs.
METHODS: This single-center, randomized, open-label, phase III trial will enroll patients with FDG-avid, well-differentiated GEP-NETs. Participants will be randomized in a 1:1 ratio to receive either PRRT alone or PRRT plus CAPE-TEM chemotherapy. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate, overall survival, toxicity, and quality of life parameters. The sample size of 162 patients was calculated based on the assumption that the addition of chemotherapy would improve PFS by an absolute value of 15% compared to the PRRT arm of the NETTER-1 trial.
DISCUSSION: The combination of PRRT and chemotherapy may enhance treatment efficacy by targeting both somatostatin receptor-positive and FDG-avid tumor cells. By addressing the lack of prospective data on the efficacy of PRRT combined with chemotherapy in NETs, this trial aims to provide valuable insights into the benefits and risks of this combination. The results of this study have the potential to significantly impact the treatment strategies for patients with aggressive NETs, potentially improving the outcomes and quality of life of this patient population.
TRIAL REGISTRATION: This trial is registered with the Clinical Trials Registry of India (CTRI/2019/07/027255) and ClinicalTrials.gov ID: NCT07185672.
METHODS: This single-center, randomized, open-label, phase III trial will enroll patients with FDG-avid, well-differentiated GEP-NETs. Participants will be randomized in a 1:1 ratio to receive either PRRT alone or PRRT plus CAPE-TEM chemotherapy. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate, overall survival, toxicity, and quality of life parameters. The sample size of 162 patients was calculated based on the assumption that the addition of chemotherapy would improve PFS by an absolute value of 15% compared to the PRRT arm of the NETTER-1 trial.
DISCUSSION: The combination of PRRT and chemotherapy may enhance treatment efficacy by targeting both somatostatin receptor-positive and FDG-avid tumor cells. By addressing the lack of prospective data on the efficacy of PRRT combined with chemotherapy in NETs, this trial aims to provide valuable insights into the benefits and risks of this combination. The results of this study have the potential to significantly impact the treatment strategies for patients with aggressive NETs, potentially improving the outcomes and quality of life of this patient population.
TRIAL REGISTRATION: This trial is registered with the Clinical Trials Registry of India (CTRI/2019/07/027255) and ClinicalTrials.gov ID: NCT07185672.
Предметные рубрики MeSH
HumansNeuroendocrine TumorsStomach NeoplasmsPancreatic NeoplasmsIntestinal NeoplasmsOctreotideAntineoplastic Combined Chemotherapy ProtocolsOrganometallic CompoundsFemaleMaleFluorodeoxyglucose F18TemozolomideCapecitabineMiddle AgedAdultClinical Trials, Phase III as TopicRandomized Controlled Trials as TopicReceptors, PeptideAgedRadiopharmaceuticalsLutetium