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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
oral low dose of capecitabine
Lu-PRRT (at 3.7Gbq per cycle x 7 cycles)
long acting octreotide or lanreotide
Irst Irccs
Meldola, FC, Italy
Progression free survival
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.
Time frame: up to 72 months
Disease control rate
DCR will be evaluated using the new international criteria proposed by the Version 1.1 Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: up to 72 months
Acute and late toxicity
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 and a profile of adverse events related to the study drug will be described.
Time frame: up to 72 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.