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

NCT02736448 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-01-13

No results posted yet for this study

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.

Conditions

  • Gastro-entero-pancreatic Neuroendocrine Tumors

Interventions

DRUG

Capecitabine

oral low dose of capecitabine

DRUG

Lu-PRRT

Lu-PRRT (at 3.7Gbq per cycle x 7 cycles)

DRUG

SS-LAR

long acting octreotide or lanreotide

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Giovanni Paganelli, MD · IRST IRCCS, Meldola (FC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-08-31
Completion
2023-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736448 on ClinicalTrials.gov