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

Wake Forest University (WFU)

Status

Terminated

Conditions

Non-small Cell Lung Cancer

Treatments

Radiation: thermal ablation with external beam radiation

Study type

Interventional

Funder types

Other

Identifiers

NCT01028612

CCCWFU 62109 (Other Identifier)

IRB00011975

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.