NCT00499447CompletedNot Applicable
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
Wake Forest University Health Sciences2 sites in 1 country13 target enrollmentStarted: May 2007Last updated:
Conditions
Interventions
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
Experimental
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
Experimental
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
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 2
Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung CancerLung CancerNCT00039507Fox Chase Cancer Center
Completed
Phase 2
Radiofrequency Interstitial Tissue Ablation in Treating Patients With Localized Renal Cell Carcinoma (Kidney Cancer)Kidney CancerNCT00019955National Cancer Institute (NCI)
Completed
Not Applicable
Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in SituBreast CancerNCT00388115University of California, Davis15
Completed
Phase 2
Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and MetastasesKidney CancerMetastatic CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00006255Case Comprehensive Cancer Center17
Completed
Phase 1
Palliative Radiofrequency Ablation in Metastatic Renal Cell Carcinoma PatientsCarcinoma, Renal CellNCT00891475Kidney Cancer Research Bureau114