A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Two Year Progression Free Survival Rate
Study Overview
Brief Summary
RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
- To determine progession free survivial rates in patients with inoperable stage IA and select stage IB non-small cell lung cancer treated with external-beam radiation therapy and radiofrequency ablation (RFA).
Secondary
- To determine the acute and late toxicity of combining RFA with external-beam radiation therapy.
- To determine the patterns of failure at time of first relapse.
- To determine the rate of overall survival at 1 and 2 years after treatment.
- To evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior to RFA to predict local control and time to progression.
- To measure post RFA/simulation (treatment planning) PET max and peak SUV's and correlate this data with local control at 1 and 2 years.
- To evaluate the ability of peak and max SUV's for fludeoxyglucose F 18 obtained shortly after radiotherapy (post-treatment) to predict local control and time to progression.
- To evaluate PET-CT data and its utility in guiding radiation therapy treatment planning.
- To explore the use of dual time point imaging PET data obtained to predict local control and also to differentiate between recurrence versus inflammation when applicable.
- To assess physical function as a prognostic measure, and to determine the impact of treatment on physical function.
- To evaluate the impact of treatment on generic and disease-specific quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ECOG performance status 0-2
- •Women of childbearing potential must have a negative pregnancy test
- •Fertile women must use effective contraception
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 level < 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 study entry
- •Pregnant or lactating women
- •PRIOR CONCURRENT THERAPY:
- •Exclusion Criteria:
- •Previous chest radiation to the lung or mediastinum
- •Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
- •Radiotherapy
- •Radiofrequency ablation
- •Other antineoplastic interventional radiology techniques
- •Chemotherapy
- •Biological therapy
- •Vaccine therapy
- •Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowed
Arms & Interventions
Radiofrequency Ablation with External Beam Radiation
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
Intervention: radiofrequency ablation (Procedure)
Radiofrequency Ablation with External Beam Radiation
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
Two Year Progression Free Survival Rate
Time Frame: 2 years
the number of patients surviving progression-free at two years.
Secondary Outcomes
No secondary outcomes reported
