NCT02736500|CompletedPhase 1/2
Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors
LuX
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Sponsor study identifier
interventional
39
1 country
2
Study Start
September 2, 2015
Actual (reported)Primary Completion
April 2017
Actual (reported)Study Completion
October 22, 2019
Actual (reported)The aim of this phase I-II study is to evaluate the efficacy and toxicity of PRRT with 177Lu-DOTATATE (Lu-PRRT) associated to metronomic chemotherapy with Capecitabine in patients affected by aggressive FDG-positive gastro-entero-pancreatic NET. Moreover to analyze the effects of the capecitabine metronomic schedule on the level of circulating angiogenetic factors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 22, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2015
Actual (reported)April 7, 2016
Actual (reported)April 13, 2016
Actual (reported)April 2017
Actual (reported)October 22, 2019
Actual (reported)Objective Overall Response Rate
rate of objective clinical response (complete response (CR), partial response (PR), or minor response (MR) according to RECIST criteria
up to 24 months
toxicity rate
The rate of toxicity, either acute or delayed, according to NCI criteria, of the association 177Lu-DOTATATE and metronomic capecitabine.
up to 24 months
Progression free survival in association with histopathology characteristics
up to 24 months
Progression free survival in association with the receptor and metabolic status at OctreoScan and FDG PET
up to 24 months
5 cycles of 5.5 GBq (150 mCi) each, up to the total cumulative activity of 28 GBq (750 mCi) 177Lu-DOTATATE
6 cycles of 3.7 GBq (100 mCi) each, up to the total cumulative activity of 22 GBq (600 mCi) 177Lu-DOTATATE
Patients without risk factors (particularly long standing and poorly controlled diabetes and hypertension) for late renal toxicity will be administered with 5 cycles of 5.5 GBq (150 mCi) each, up to the total cumulative activity of 28 GBq (750 mCi) of 177Lu-DOTATATE.
Patients with risk factors for late renal toxicity will be administered with 6 cycles of 3.7 GBq (100 mCi) each, up to the total cumulative activity of 22 GBq (600 mCi)177Lu-DOTATATE
Giovanni Paganelli
Meldola, FC, 47014, Italy
Lisa Bodei
Milan, Italy
Giovanni Paganelli, MD
IRST IRCCS, Meldola (FC)
39 participants (actual enrollment reported by the registry).
First Submitted
April 7, 2016
First Posted
April 13, 2016
Study Start
September 2, 2015
Actual (reported)Evaluation of [18F]Fluoroethyl Triazole Labelled [Tyr3]-Octreotate Analogues for the Imaging of Neuroendocrine Tumours.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 2017
Actual (reported)Study Completion
October 22, 2019
Actual (reported)Last Updated
January 13, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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