177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors

Summary

This is a randomized phase II, parallel group study. Patients with gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) well differentiated G1 - G2 (ki67≤ 20%) and G3 (ki67≤ 50%), somatostatin receptor (SSR) positive and 18-FDG positive will be enrolled in the study and will be randomly assigned to 2 different arms: * Arm Lu-PRRT-Cap: oral low dose of capecitabine in association with Lu-PRRT (at 3.7 Gbq per cycle x 7 cycles) followed by long acting octreotide or lanreotide (SS-LAR); OR * Arm Lu-PRRT: Lu-PRRT (at 3.7 gigabecquerel (Gbq) per cycle x 7 cycles) followed by SS-LAR.

Timeline

Start

2016-05

Primary completion

2019-08

Completion

2023-04-30

Outcome

Outcome not reported

Stopped: “Following the publication in the Official Journal of the reclassification of the drug LUTATHERA in band H, it was decided to close the enrolment early on 30/Aug/19.”

Drugs

Indications