A controlled clinical study comparing the efficacy and safety of a new treatment option (peptide receptor radionuclide therapy, PRRT) for tumors of the gastrointestinal tract and pancreas compared to targeted molecular therapy with the current standard treatment (Everolimus).
Zusammenfassung der Studie
This clinical study aims to compare two different treatment options: on one hand, the current standard treatment with Everolimus in tablet form. On the other hand, peptide receptor radionuclide therapy (PRRT), which is based on the administration of a radioactive drug (177Lu-Edotreotid). This PRRT is a new treatment that is not yet approved. The goal of both treatments is to slow tumor growth or achieve a reduction in tumor size. By including both untreated and previously treated patients, the question of the best timing for PRRT is also investigated. Similar to flipping a coin, it is decided how all study participants will be distributed across the two treatment arms. In total, 300 GEP-NET patients will be treated in the study. Two-thirds of the patients will receive PRRT (200 patients) and one-third (100 patients) will receive Everolimus. The PRRT consists of a maximum of four treatments, during which 177-Lu-Edotreotid is administered as an infusion into the vein every 3 months. Patients in the Everolimus arm will receive 10 mg of Everolimus (Afinitor®) daily in tablet form throughout the study duration. The total duration of the study will be 30 months for all patients. During the study, a series of examinations will be conducted at one to three-month intervals to check the patient's health status. If the disease progresses during the study (tumor progression), study participation must be terminated. After the final visit, the study physician will regularly contact the patient by phone to inquire about their condition.
(BASEC)
Untersuchte Intervention
In the Compete study, patients with inoperable GEP-NET neuroendocrine tumors of the gastrointestinal tract or pancreas are treated.
This type of tumor belongs to a group of slowly growing malignant tumors.
(BASEC)
Untersuchte Krankheit(en)
Treatment of patients with well-differentiated, somatostatin receptor-positive, inoperable or metastatic neuroendocrine tumors (NETs) of gastrointestinal or pancreatic origin.
(BASEC)
Women and men ≥ 18 years Histologically and clinically confirmed diagnosis of a well-differentiated neuroendocrine tumor of non-functional gastrointestinal origin or functional or non-functional pancreatic tumor (P-NET), inoperable or with metastases in other body organs Radiologically confirmed tumor progression Somatostatin receptor-positive disease (SSTR+) (BASEC)
Ausschlusskriterien
Known hypersensitivity to Edotreotid or Everolimus, DOTA, Lutetium-177, or other components of Edotreotid or Everolimus or to L-lysine, L-arginine, or other components of the kidney-protective amino acid solution Previous peptide receptor radionuclide therapy (PRRT) Previous therapy with mTor inhibitors Pregnancy or breastfeeding (BASEC)
Studienstandort
Basel, Bern, Zürich
(BASEC)
Sponsor
ITM Solucin GmbH Lichtenbergstrasse 1 D-85748 Garching, Germany
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Viviane Hess
0041 61 265 50 74/59
Viviane.Hess@clutterusb.chUniversitätsspital Basel, Klinik für Onkologie, Petersgraben 4, CH-4031 Basel, Switzerland
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
28.06.2017
(BASEC)
ICTRP Studien-ID
NCT03049189 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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, somato-statin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET) COMPETE (BASEC)
Wissenschaftlicher Titel
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) (ICTRP)
Öffentlicher Titel
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (ICTRP)
Untersuchte Krankheit(en)
Neuroendocrine Tumors (ICTRP)
Untersuchte Intervention
Drug: 177Lu-edotreotide PRRT;Drug: Everolimus;Other: Amino-Acid Solution (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of
non-functional gastroenteric origin (GE-NET) or both functional or non-functional
pancreatic origin (P-NET)
- Measurable disease per RECIST 1.1
- Somatostatin receptor positive (SSTR+) disease
- Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological
imaging examinations made with the same imaging method (either CT or MRI)
Exclusion Criteria:
- Known hypersensitivity to edotreotide or everolimus
- Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or
everolimus or any other Rapamycin derivative
- Prior exposure to any peptide receptor radionuclide therapy (PRRT)
- Prior therapy with mTor inhibitors
- Prior EFR (external field radiation) to GEP-NET lesions within 90 days before
randomisation or radioembolisation therapy
- Therapy with an investigational compound and/or medical device within 30 days prior to
randomisation
- Indication for surgical lesion removal with curative potential
- Planned alternative therapy (for the period of study participation)
- Serious non-malignant disease
- Clinically relevant renal, hepatic, cardiovascular, or haematological organ
dysfunction, potentially interfering with the safety of the study treatments
- Pregnant or breast-feeding women
- Subjects not able to declare meaningful informed consent on their own (e.g. with legal
guardian for mental disorders) or any other vulnerable population to that sense (e.g.
persons institutionalised, incarcerated etc.).
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
progression-free survival (PFS) (ICTRP)
overall survival (OS) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
ABX CRO;PSI CRO (ICTRP)
Weitere Kontakte
Nicolas Schneider, Dr, info@itm-solucin.de (ICTRP)
Sekundäre IDs
ITM-LET-01 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03049189 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar