Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

September 2, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

October 22, 2019

Conditions
Neuroendocrine TumorsGastro Entero Pancreatic Neuroendocrine Tumors
Interventions
DRUG

28 GBq 177Lu-DOTATATE

Patients without risk factors (particularly long standing and poorly controlled diabetes and hypertension) for late renal toxicity will be administered with 5 cycles of 5.5 GBq (150 mCi) each, up to the total cumulative activity of 28 GBq (750 mCi) of 177Lu-DOTATATE.

DRUG

22 GBq 177Lu-DOTATATE

Patients with risk factors for late renal toxicity will be administered with 6 cycles of 3.7 GBq (100 mCi) each, up to the total cumulative activity of 22 GBq (600 mCi)177Lu-DOTATATE

Trial Locations (2)

47014

Giovanni Paganelli, Meldola

Unknown

Lisa Bodei, Milan

All Listed Sponsors
collaborator

Istituto Europeo di Oncologia

OTHER

lead

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

NCT02736500 - Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors | Biotech Hunter | Biotech Hunter