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).
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Bâle, Berne, Zurich
(BASEC)
Sponsor
ITM Solucin GmbH Lichtenbergstrasse 1 D-85748 Garching, Germany
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Viviane Hess
0041 61 265 50 74/59
Viviane.Hess@clutterusb.chUniversitätsspital Basel, Klinik für Onkologie, Petersgraben 4, CH-4031 Basel, Switzerland
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
28.06.2017
(BASEC)
Identifiant de l'essai ICTRP
NCT03049189 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (ICTRP)
Maladie en cours d'investigation
Neuroendocrine Tumors (ICTRP)
Intervention étudiée
Drug: 177Lu-edotreotide PRRT;Drug: Everolimus;Other: Amino-Acid Solution (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
progression-free survival (PFS) (ICTRP)
overall survival (OS) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
ABX CRO;PSI CRO (ICTRP)
Contacts supplémentaires
Nicolas Schneider, Dr, info@itm-solucin.de (ICTRP)
ID secondaires
ITM-LET-01 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03049189 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible