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Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.
Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.
Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:
Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
Efficacy -
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| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Time from DaRT insertion to disease progression (according to RECIST V1.1) or death, whichever occurs first | Up to 60 months following DaRT insertion |
| Adverse Events (AE) | Assessment of late onset of Alpha DaRT related AE | Up to 60 months following DaRT insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Time from partial or complete response to the first disease progression according to RECIST V1.1 | Up to 60 months following DaRT insertion |
| Overall Survival (OS) | Time from DaRT insertion to death |
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Inclusion Criteria:
Exclusion Criteria:
None.
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The medical records of patients previously treated with Alpha DaRT as part of the completed clinical trial "CTP-SCC-00" will be accessed to follow up with their status, if available.
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| Name | Affiliation | Role |
|---|---|---|
| Noga Kurman, MD | Davidof Cancer Institution at Rabin Medical Center Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davidof Cancer Institution at the Rabin Medical Center Israel | Petah Tikva | 49100 | Israel | |||
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Up to 60 months following DaRT insertion |
| Meldola |
| Italy |
| D018307 |
| Neoplasms, Squamous Cell |