Patients with metastatic renal cancer, melanoma or sarcoma, or with non-metastatic sarcoma (soft tissue, chondrosarcoma, osteosarcoma…), and with a progressive / recurrent inoperable musculoskeletal tumor lesion.
Conditions
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Male or female patients aged of at least 18 years on day of signing informed consent. I2. Histologically-confirmed diagnosis of: - Metastatic renal cancer, sarcoma, or melanoma, with the presence of at least one progressive / recurrent inoperable musculoskeletal tumor lesion eligible for radiotherapy Note: - Only one lesion can be treated with this protocol. - Long bones should be excluded this is not a good indication for stereotactic radiotherapy. - or Non-metastatic sarcoma with musculoskeletal tumor lesion eligible for radiotherapy i.e.: o inoperable o partially resected with macroscopic (R2) residual tumor o locally recurrent lesion after surgery (R0 or R1). I3. For metastatic patients: o Currently being treated with first- or second-line therapy in the metastatic setting. o No RECIST v1.1 progression of tumor lesions that will not be treated by RT, documented by radiological assessment within 4 weeks before inclusion. o Radiological evidence of a maximum of 5 metastases in less than 3 organs. I4. Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. I5. Life expectancy of at least 12 months. I6. For vertebral metastatic lesions, Spinal Instability Neoplastic Score (SINS) =65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: E1. Patients participating to another clinical trial with an investigational agent. E2. Patients who have not recovered from significant adverse events (i.e. grade > 2 AE according to NCI CTCAE v5.0) due to prior treatment with anti-cancer agents with the exception of any grade alopecia or lab values presented in inclusion criteria I8. E3. Patients with carcinomatous meningitis, peritoneal carcinosis or bone marrow involvement. E4. Patients with prior local treatment with radiotherapy of the tumor lesion eligible for this protocol. E5. Patients currently treated with Bevacizumab. E6. Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of concomitant medications. E7. Patients with known arterio-venous malformation near the treatment area. E8. Patients unable to undergo or tolerate Magnetic Resonance Imaging or with known contra-indication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements or certain metal implants). E9. Patients with known contra-indication, sensitivity or allergy to gadolinium. E10. Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate study drug or would likely interfere with study procedures or results. E11. Patients who are pregnant or breastfeeding women or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 3 months after the last dose of trial treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical impact of IV injections of AGuIX® nanoparticles in combination with radiotherapy versus radiotherapy only in patients with progressive inoperable musculoskeletal tumor lesion.;Secondary Objective: - To further document the clinical impact of the proposed therapeutic strategy versus radiotherapy only. - To assess the safety of the proposed therapeutic strategy versus radiotherapy only. - To evaluate the impact of the proposed strategy versus radiotherapy only on patient quality of life.;Primary end point(s): Local progression free survival assessed by Blinded Independent Central Review (BICR).;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Rate of tumor response at 6-months and 1-year considering partial response (PR) as = 30% decrease in longest diameter and complete response (CR) as complete disappearance of the treated lesion assessed by BICR; - Variation of treated lesion volume at 6-months and 1-year after radiotherapy assessed by BICR; - Time to first subsequent systemic therapy; - Overall survival. - Short-term toxicity related to AGuIX® multiple IV injections in combination with RT from D1 to STSV: Nature, frequency and severity of Adverse Events (AEs), Adverse Events of Special Interest (AESI), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) graded using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.; - Long term toxicity (AESI) up to overall study completion for all treated patients. - Evolution of Quality of life (QLQ-C30 questionnaires);Timepoint(s) of evaluation of this end point: at 6-months and 1-year after radiotherapy | — |
Countries
France
Contacts
Public ContactDRCI
Centre Léon Bérard
Outcome results
None listed