Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
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|ClinicalTrials.gov Identifier: NCT03049189|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : June 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: 177Lu-edotreotide PRRT Drug: Everolimus Other: Amino-Acid Solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)|
|Actual Study Start Date :||February 2, 2017|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2029|
Experimental: 177Lu-edotreotide PRRT
A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each.
Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
Drug: 177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Other: Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
Other Name: Arginine-Lysine Solution
Active Comparator: Everolimus
Everolimus (Afinitor ®)
Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)
Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Other Name: Afinitor
- progression-free survival (PFS) [ Time Frame: 12 weeks +/- 14 days, up to 30 months ]PFS will be assessed individually per patient from date of randomization until the date of first documented progression, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days
- overall survival (OS) [ Time Frame: every 3 months for a period of at least 30 months ]OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049189