Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size



Status:Terminated
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:February 2010
End Date:November 2011

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A Pilot Study of Interventional Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

The main objective of this study is to assess the initial safety of the combination of
interventional ablation and external beam radiotherapy including acute and late toxicity (90
days) for patients with early stage lung cancer.


Inclusion Criteria:

- Patients with AJCC sixth edition Stage Ib or II non-small-cell lung cancer with
cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible.

- 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:

- History of prior malignancy within the past 2 years except for curatively treated
basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous
cell carcinoma of the larynx, or localized prostate cancer with a current PSA of < 1.0
mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent
evaluation no more than 4 weeks prior to entry

- 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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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