Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03290534|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2017
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Lung Cancer Stage I Lung Cancer Stage II||Device: CivaSheet||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: CivaSheet Directional LDR Brachytherapy
FDA Cleared CivaSheet directional Pd-103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
implanting CivaSheet for localized radiation dose delivery
Other Name: brachytherapy
- Local Control Rate at 1 year [ Time Frame: 1 year ]The local control rate in the region irradiated by CivaSheet.
- Freedom from regional or distant recurrence [ Time Frame: 1 year ]Control rate for recurrences outside the local area irradiated by CivaSheet.
- Time to recurrence [ Time Frame: 1 year ]Time in months to any recurrence
- Toxicity graded on CTCAE 4.0 Scale [ Time Frame: 1 year ]pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290534
|Contact: Carra Castagnerofirstname.lastname@example.org|
|Contact: Kristy Perez, PhDemail@example.com|
|Principal Investigator:||Abe Wu, MD||MSKCC|