Informations générales (source: ClinicalTrials.gov)
Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial. (NANORAD2)
Interventional
Phase 2
University Hospital, Grenoble (Voir sur ClinicalTrials)
mars 2019
mars 2025
29 juin 2024
This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study
will be adaptive: an interim analysis is planned after enrolment of 20 patients in each
arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s)
that present the best response rate to the experimental treatment (AGuIX® + WBRT).
The main endpoint will be evaluated by a blinded endpoint committee.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:23 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 04/09/2024 13:49:29 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier universitaire Grenoble-Alpes - 38700 - Grenoble - Rhones-Alpes - France | Contact (sur clinicalTrials) | ||||
| Crlcc Francois Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Annecy Genevois - 74374 - Annecy - Rhones-Alpes - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard Lyon - 69373 - Lyon - Rhones Alpes - France | Contact (sur clinicalTrials) | ||||
| CRLCC - Institut Bergonié - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon-Hôpital Lyon Sud - 69495 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie - 31059 - Toulouse - Occitanie - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine ALEXIS VAUTRIN - 54519 - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut Régional du Cancer - 34298 - Montpellier - Occitanie - France | Contact (sur clinicalTrials) | ||||
| La Pitié Salpêtrière - Charles Foix - 75651 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Patients with brain metastases, from a histologically confirmed solid tumor,
eligible for WBRT
- At least 18 years old
- Signed informed consent after informing the patient
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Extracranial disease:
- Complete or partial response or stability under systemic treatment
- No extracranial disease
- Or first line of treatment
- Life expectancy greater than 6 weeks
- Effective contraceptive method for all patient of childbearing potential
- Affiliated to a social security regimen
- Patients with brain metastases, from a histologically confirmed solid tumor,
eligible for WBRT
- At least 18 years old
- Signed informed consent after informing the patient
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Extracranial disease:
- Complete or partial response or stability under systemic treatment
- No extracranial disease
- Or first line of treatment
- Life expectancy greater than 6 weeks
- Effective contraceptive method for all patient of childbearing potential
- Affiliated to a social security regimen
- Leptomeningeal metastasis
- Evidence of metastasis with recent large hemorrhage
- Progressive and threatening extracranial disease under systemic treatment
- Previous cranial irradiation (except stereotactic irradiation)
- Known contra-indication, sensitivity or allergy to gadolinium
- Known contra-indication for Magnetic Resonance Imaging
- Renal insufficiency (glomerular filtration rate ≤ 50 mL/min/1.73m²)
- Pregnancy or breastfeeding
- Subject under administrative or judicial control