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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 177Lutethium - Peptide Receptor Radionuclide Therapy (Lu-PRRT) Plus Capecitabine Versus Lu-PRRT in FDG Positive, Gastro-entero-pancreatic Neuroendocrine Tumors: a Randomized Phase II Study.

Brief 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.

Detailed 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%), SSR positive and 18-fluorodeoxyglucose (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 3.7Gbq per cycle x 7 cycles) followed by SS-LAR. The primary objective is to evaluate the progression free survival (PFS) in the two arms.

The secondary objectives are: i) the efficacy (disease control rate, DCR), ii) acute and late toxicity, and iii) overall survival (OS).

The investigators plan to enroll 176 patients during a period of 36 months and a period of 36 months of follow up


Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Current Primary Outcome: Progression free survival [ Time Frame: up to 72 months ]

Progression free survival is defined as the time from the randomization date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease control rate [ Time Frame: up to 72 months ]
    DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).
  • toxicity [ Time Frame: up to 72 months ]
    The acute toxicity is the toxicity that occurred within 30 days from the last treatment administration. The late toxicity is the toxicity that occurred over 30 days from the last treatment administration. NCI-CTCAE v. 4.03 will be applied


Original Secondary Outcome: Same as current

Information By: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Dates:
Date Received: April 7, 2016
Date Started: May 2016
Date Completion: April 2021
Last Updated: September 28, 2016
Last Verified: September 2016