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Study prematurely terminated following the decision by industrial partner to withdraw from the project (product supply issue).
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This is a prospective multicenter non-randomized phase II study: proton therapy with nanoparticles based on polysiloxane and gadolinium chelates injectable intravenously
This is a prospective multicenter non-randomized phase II study: proton therapy with nanoparticles based on polysiloxane and gadolinium chelates injectable intravenously in recurrent tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation by protontherapy associated to nanoparticles injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation by protontherapy associated to nanoparticles injection | Radiation | Treatment for the study will be based on proton therapy and the administration of AGuIX® nanoparticles. Protontherapy will be carried out for 4 consecutive weeks with 5 sessions per week (20 sessions) from D1 to D26. The administration of the AGuIX® nanoparticle will be done on Days 1, 8 and 15 during protontherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local efficacy of a treatment combining the administration of nanoparticles with proton therapy | proportion of patients alive and without local progression two years after the start of proton therapy (local progression-free survival rate) | 2 years after the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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