Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size
NCT ID: NCT01028612
Last Updated: 2018-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2010-02-28
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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thermal ablation with external beam radiation
thermal ablation with external beam radiation
thermal ablation with external beam radiation
Interventions
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thermal ablation with external beam radiation
thermal ablation with external beam radiation
Eligibility Criteria
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Inclusion Criteria
* To be considered node negative for N2 disease, patients will have mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on FDG PET in those areas.
* All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to co-morbid conditions.
* The CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion is determined to be in a location where RFA is technically achievable based on the proximity of adjacent organs and structures.
* Age ≥ 18 years old
* Performance Status 0-2 (ECOG)
Exclusion Criteria
* Previous chest radiation to the region of interest.
* Pregnant or lactating women.
* A clinical diagnosis of bronchoalveolar carcinoma (BAC) will be made for patients in whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the following radiographic criteria are met.
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU 62109
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00011975
Identifier Type: -
Identifier Source: org_study_id
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