Clinical Trial: Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Peptide Receptor Radionuclide Therapy (PRRT) With Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PE
Brief Summary: This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).
Detailed Summary:
This is a randomized phase II non-comparative study. Patients with GEP-NET G1-G2 with progressive disease, somatostatin receptor (SSR) positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq). The two levels of dosages are:
- Total activity of 25.9 GBq 100 mCi for 7 cycles at 6 ± 2 weeks (700 mCi)
- Total activity of 18.5 GBq 100 mCi for 5 cycles at 6 ± 2 weeks (500 mCi) The randomized study design allows for two active treatments to be evaluated in a comparable patient population. The estimates of primary objectives can be evaluated for each regimen separately by a Bryant and Day design. While the sample size is not powered for statistical test of a specific hypothesis for comparison between groups, this study design allows the unbiased collection of activity and safety in these two regimens in the same population, which will be useful for planning future studies.
Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Current Primary Outcome:
- Disease control rate (DCR) [ Time Frame: up to 7 years ]the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population randomly assigned to two different scheme of therapy
- Acute toxicity evaluated according to version 4.0 CTCAE [ Time Frame: The evaluation of the acute toxicity starts from the 1st treatment until 30 days after the last treatment cycle, up to 60 wks for each patient ]The co-primary objective is the acute toxicity evaluated according to version 4.0 CTCAE
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression free survival [ Time Frame: up to 7 years ]the time from the start treatment 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.
- Overall survival [ Time Frame: up to 7 years ]Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.
- Late toxicity evaluated according to version 4.0 CTCAE [ Time Frame: up to 7 years ]late toxicity will be evaluated during the whole study period according to version 4.0 CTCAE
Original Secondary Outcome: Same as current
Information By: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Dates:
Date Received: June 16, 2015
Date Started: December 2013
Date Completion: December 2020
Last Updated: September 28, 2016
Last Verified: September 2016
