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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days).

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 62109

NCT ID:

NCT01028612

Start Date:

February 2010

Completion Date:

November 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157