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ILUMINET: 177Lu-DOTA-TATE in Neuroendocrine Tumors

NCT01456078Phase 2

Key facts

Status: Completed
Start: Oct 2011
Primary completion: Nov 2018
Countries: 1
Sponsor: Skåne University Hospital
Modality: Peptides, Small Molecules

Drugs: lutetium Lu 177 dotatate
Conditions: neuroendocrine tumors (NETs)

Overview

Phase 2, open-label, single-arm trial of lutetium Lu 177 dotatate in neuroendocrine tumors (NETs), sponsored by Skåne University Hospital. Primary endpoint: Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy. Started Oct 2011; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

177Lu-DOTA-TATE
Personalized dosimetry-based 177Lu-DOTA-TATE treatment

Who it enrols

Patients with histologically verified neuroendocrine tumors, Ki67 <= 20% (inferred from exclusion), measurable disease, and progression on somatostatin analogues.

Endpoints

Primary

Objective tumor response after a cumulative kidney biologically effective dose (BED) of 27 +/- 2 Gy3 months after completed step 1

Secondary

Objective tumor response after receiving a cumulative BED to the kidneys of 40 +/- 2 Gy3 months after completing step 2

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