Radiotherapy Clinical Trial
— NANORAD2Official title:
Radiotherapy of Multiple Brain Metastases Using AGuIX® Gadolinium-chelated Polysiloxane Based Nanoparticles: a Prospective Randomized Phase II Clinical Trial.
Verified date | August 2023 |
Source | University Hospital, Grenoble |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | March 26, 2025 |
Est. primary completion date | June 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Annecy Genevois | Annecy | Rhones-Alpes |
France | CRLCC - Institut Bergonié | Bordeaux | |
France | Crlcc Francois Baclesse | Caen | |
France | Centre Georges François Leclerc | Dijon | |
France | Centre Hospitalier Universitaire Grenoble-Alpes | Grenoble | Rhones-Alpes |
France | Centre Leon Berard Lyon | Lyon | Rhones Alpes |
France | Hospices Civils de Lyon-Hôpital Lyon Sud | Lyon | |
France | Institut Régional du Cancer | Montpellier | Occitanie |
France | Hôpital Européen Georges Pompidou | Paris | |
France | La Pitié Salpêtrière - Charles Foix | Paris | |
France | Institut Curie Saint Cloud | Saint-Cloud | |
France | Crlcc Paul Strauss | Strasbourg | |
France | Institut Claudius Regaud Institut Universitaire du Cancer Toulouse Oncopole Radiothérapie | Toulouse | Occitanie |
France | Institut de Cancérologie de Lorraine ALEXIS VAUTRIN | Vandœuvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble | NH TherAguix SAS |
France,
Le Duc G, Miladi I, Alric C, Mowat P, Brauer-Krisch E, Bouchet A, Khalil E, Billotey C, Janier M, Lux F, Epicier T, Perriat P, Roux S, Tillement O. Toward an image-guided microbeam radiation therapy using gadolinium-based nanoparticles. ACS Nano. 2011 Dec 27;5(12):9566-74. doi: 10.1021/nn202797h. Epub 2011 Nov 9. — View Citation
Lux F, Tran VL, Thomas E, Dufort S, Rossetti F, Martini M, Truillet C, Doussineau T, Bort G, Denat F, Boschetti F, Angelovski G, Detappe A, Cremillieux Y, Mignet N, Doan BT, Larrat B, Meriaux S, Barbier E, Roux S, Fries P, Muller A, Abadjian MC, Anderson C, Canet-Soulas E, Bouziotis P, Barberi-Heyob M, Frochot C, Verry C, Balosso J, Evans M, Sidi-Boumedine J, Janier M, Butterworth K, McMahon S, Prise K, Aloy MT, Ardail D, Rodriguez-Lafrasse C, Porcel E, Lacombe S, Berbeco R, Allouch A, Perfettini JL, Chargari C, Deutsch E, Le Duc G, Tillement O. AGuIX(R) from bench to bedside-Transfer of an ultrasmall theranostic gadolinium-based nanoparticle to clinical medicine. Br J Radiol. 2019 Jan;92(1093):20180365. doi: 10.1259/bjr.20180365. Epub 2018 Sep 18. — View Citation
Verry C, Dufort S, Barbier EL, Montigon O, Peoc'h M, Chartier P, Lux F, Balosso J, Tillement O, Sancey L, Le Duc G. MRI-guided clinical 6-MV radiosensitization of glioma using a unique gadolinium-based nanoparticles injection. Nanomedicine (Lond). 2016 Sep;11(18):2405-17. doi: 10.2217/nnm-2016-0203. Epub 2016 Aug 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best objective intracranial response rate - intent-to-treat | Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST) by MRI, with MRI centralized reading | at 6 weeks | |
Primary | Best objective intracranial response rate - intent-to-treat | Evaluation of brain metastases response, according to RECIST v1.1 criteria (or modified RECIST) by MRI, with MRI centralized reading | at 3 months | |
Secondary | Evaluation of the quality of life | Quality of life test score EORTC QLQ C30 | at D0, 6 weeks, 3, 6, 9, 12 months | |
Secondary | Evaluation of the quality of life | Quality of life test score EORTC QLQ BN20 | at day 0, 6 weeks, 3, 6, 9, 12 months | |
Secondary | Neurocognitive evaluation | Neurocognitive test (MoCA) | at Day 0, 6 weeks, 3, 6, 9, 12 months | |
Secondary | Best objective intracranial response rate - per-protocol | Evaluation of brain metastases response on per-protocol population, according to RECIST v1.1 criteria (or modified RECIST), by MRI with centralized reading | at 6 weeks and 3 months | |
Secondary | Evaluation of the intracranial response rate | Evaluation of brain metastases response, according to RANO, to RECIST v1.1 criteria, and as the evolution of the sum of longest diameters (for all metastases with a sum of diameters > 1cm), by MRI, at 6 weeks and 3, 6, 9 and 12 months | for 12 months | |
Secondary | Evaluation of individual metastasis response | Evaluation of individual brain metastasis response, for all metastases with the sum of diameters > 1cm, by MRI rate | at 6 weeks and 3, 6, 9 and 12 months | |
Secondary | Intracranial progression-free survival | Evaluation of the time between the start of the treatment and the occurence of intracranial progression or neuriologic death | at 12 months | |
Secondary | Intracranial progression-free survival, brain survival | Death related to brain metastases progression | at 12 months | |
Secondary | Overall survival | Death | at 12 months | |
Secondary | Change in steroid dependence | Reporting of daily steroid dose | at 6 weeks and 3, 6, 9 and 12 months | |
Secondary | Incidence of adverse events | Reporting of adverse events by type, frequency and severity for both treatments (WBRT and AGuIX® + WBRT) | at 6 weeks and 3, 6, 9 and 12 months | |
Secondary | MRI study of the distribution of the product in brain metastases | MRI evaluation of contrast enhancement at D0 after AGuIX® injection | Day 0 |
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