A Phase II study evaluating AGuIX® nanoparticles in combination with Stereotactic Radiation for oligo brain metastases - Nanostéréo

Centre Léon Bérard0 个研究点目标入组 55 人开始时间: 2019年6月25日最近更新: 2021年3月8日

适应症

试验速览

暂无简介。

•I1. Male or female patients aged of at least 18 years on day of signing informed consent.
•I2. Histologically-confirmed diagnosis of any histological type of solid tumors, excluding primary Central nervous system (CNS) tumors.
•I3. Radiological evidence by MRI :
•- At least one and a maximum of 5 brain metastases, and
•- At least one brain lesion with a longest diameter = 2 cm and eligible for FSRT.
•I4. Patient without progression on extracranial disease documented by radiological assessment as per RECIST v1.1 within 4 weeks before inclusion.
•I5. For patients treated with a systemic anti-cancer therapy: a minimal 2-week washout period is required from the date of last systemic treatment administration to Day 1, except for hormonal agents.
•I6. ECOG Performance Status (PS) =2 .
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 55

•E1. Prior local treatment with radiotherapy (whole / partial brain or stereotactic radiosurgery) or surgical resection of brain lesions.
•E2. Patient participating to another clinical trial with an investigational agent.
•E3. Patients who have not recovered from significant adverse events (i.e. Grade > 2 AE according to NCI CTCAE v5.0, see Appendix 4) due to prior treatment with anti-cancer agents with exception of any Grade alopecia or lab values presented in criteria I7.
•E4. Contra-indication for MRI enhanced with gadolinium (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants).
•E5. Patients who are pregnant or breastfeeding.

发起方

Centre Léon Bérard