Study evaluating AGuIX® nanoparticles in combination with radiotherapy for brain metastases.

Phase 1

• Conditions: Brain metastases; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 20.0Level: LLTClassification code 10006128Term: Brain metastasesSystem Organ Class: 100000004864

• Registration Number: EUCTR2018-003994-80-FR
• Lead Sponsor: Centre Léon Bérard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-25
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the clinical impact of AGuIX® nanoparticles in combination with Stereotactic Radiation in oligo brain metastases.;Secondary Objective: To further evaluate the clinical activity of AGuIX® nanoparticles in combination with Stereotactic Radiation in oligo brain metastases.<br>To assess the impact of the proposed therapeutic strategy on patient quality of life (QoL) and cognition.<br>To assess the safety of the proposed therapeutic strategy.;Primary end point(s): The primary endpoint is the rate of local control;Timepoint(s) of evaluation of this end point: 1 year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Distant brain failure<br>- Time to brain relapse.<br>- Tumor target volume agreement (MRI comparisons) between D4 AGuIX®-MRI and D1 Initial screening T1-Gd-Chelate-MRI<br>- Variation of brain lesion volume at Day 45 and 3 months after the start of treatment.<br>- MRI evaluation of contrast enhancement at D4 after AGuIX® injection<br>- Overall survival.<br>;Timepoint(s) of evaluation of this end point: - Distant brain failure at 6 months and 1 year