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IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TumoCure Treatment | Experimental | Subjects will be treated with a single intra-tumor injection of TumoCure, containing the polymeric delivery system and the Cisplatin hemotherapy agent at a dose of 100mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TumoCure | Combination Product | TumoCure is a polymer-based gel, loaded with Cisplatin in a dose of 100mg (10% w/w), injected to head and neck tumors locally in a single injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Serious Adverse Events | Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tumor Size (Efficacy) | change in tumor size from baseline to the end of the follow up period (90 days) according to the RECIST methodology, as determined by MRI/CT imaging | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival (OS) throughout the follow up period (90 days) | 90 days |
| Subject Quality of Life | Subject Quality of Life (QoL), as determined by the change in EORTC-QLQ30 (European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - 30) total score (ranging from 30-120, the lower the result, the better quality of life the subject reports) from baseline to end of follow up period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Shick | Contact | 972523355442 | mayashick@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Aharon Popovizer, MD | Head of Head and Neck Surgery Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Recruiting | Jerusalem | Israel |
IPD is not planned to be shared
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| 90 days |
| Subject Quality of Life | EORTC-QLQ HNC43 (European Organization for Research and Treatment of Cancer - Quality of Life Head and Neck Questionnaire 43) questionnaire total score (ranging from 43-172, the lower the result the better quality of life the subject reports) from baseline to end of follow up period. | 90 days |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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