Lung Cancer Clinical Trial
Official title:
Feasibility Study to Treat Lung Cancer With the Permanently Implantable LDR CivaSheet®
NCT number | NCT03290534 |
Other study ID # | CT006 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | March 13, 2019 |
Est. completion date | December 2025 |
This is a feasibility study to determine the usefulness of a brachytherapy device that utilizes active components (palladium-103) of standard devices in a novel configuration, which may benefit lung cancer patients by reducing the radiation dose to critical structures, such as the heart wall, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subject signed inform consent - Suspected or proven non-small cell lung cancer (NSCLC) in the upper lobes of the left or right lung - Pre-operative criteria - Lung nodule suspicious for NSCLC - Mass = 7 cm in maximum diameter by CT scan of the chest and upper abdomen - Clinical stage I or Clinical stage II - Not pregnant or nursing - Negative pregnancy test in premenopausal women - Fertile patients must use effective contraception - More than 5 years since prior invasive malignancy unless non melanoma skin cancer or in-situ cancer Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
CivaTech Oncology |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Control Rate at 1 year | The local control rate in the region irradiated by CivaSheet. | 1 year | |
Secondary | Freedom from regional or distant recurrence | Control rate for recurrences outside the local area irradiated by CivaSheet. | 1 year | |
Secondary | Time to recurrence | Time in months to any recurrence | 1 year | |
Secondary | Toxicity graded on CTCAE 4.0 Scale | pulmonary function, radiation pneumonitis, fatigue, lung fibrosis, etc. | 1 year |
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