A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
A multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III
study. In this study, treatment with 177Lu-DOTA0-Tyr3-Octreotate plus best supportive care
(30 mg Octreotide LAR) will be compared to treatment with high dose (60 mg) Octreotide LAR
in patients with inoperable, somatostatin receptor positive, histologically proven midgut
carcinoid tumours; these patients should be progressive under Octreotide LAR. In case
patients in either arm experience clinical symptoms (i.e. diarrhoea and flushing) associated
with their carcinoid tumours, Octreotide s.c. rescue injections are allowed.
Objective tumour response in both arms will be assessed every 12±1 weeks from the first
treatment date according to RECIST Criteria. The baseline CT scan/MRI must not be older than
4 weeks before the projected randomization date.
Patients will be evaluated for safety and tolerability in accordance with the Visit
Schedules for the 177Lu-DOTA0-Tyr3-Octreotate arm and the Octreotide LAR arm as indicated in
Table 1 and Table 2, respectively.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free survival (PFS)
Primary efficacy endpoint is PFS as measured by objective tumour response, centrally assessed according to RECIST Criteria. CT/MRI tumour assessment in both arms will be performed every 12±1 weeks from the first treatment date.
12+/- 1 weeks
No
Paola Santoro, Biologist
Study Director
Advanced Accelerator Applications
United States: Food and Drug Administration
AAA-III-01
NCT01578239
September 2012
December 2017
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Mayo Clinic | Rochester, Minnesota 55905 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Duke University | Durham, North Carolina 27710 |
H Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Dana Farber Cancer Center | Boston, Massachusetts 02115 |
Cedar Sinaï Medical Center | Los Angeles, California CA90048 |
Robert H Lurie Comprehensive Cancer Center of Northwestern Univ | Chicago, Illinois 60611-3015 |
University of Iowa Hospital Clinics | Iowa City, Iowa 52242-1077 |
Oshsner Medical Center | Kenner, Louisiana 70065 |
Weill-Cornell Medical College / New York Prebyterian | New York City, New York 10065 |
University of Pennsylvania Medical School | Philadelphia, Pennsylvania 19104 |
Excel Diagnostics, Imaging Clinic | Houston, Texas 77042 |