NCT00039507CompletedPhase 2
Pilot Study: Radiofrequency Ablation Of Resectable Non-Small Cell Lung Cancer
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Fox Chase Cancer Center
- Locations
- 1
Study Overview
Brief Summary
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. Combining radiofrequency ablation with surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining radiofrequency ablation with surgery in treating patients who have stage I or stage II non-small cell lung cancer.
Detailed Description
OBJECTIVES:
- Determine the acute effects of intraoperative radiofrequency tumor ablation (RFA) in patients with resectable non-small cell lung cancer.
- Determine the treatment-related toxicity in patients treated with this therapy.
- Determine the dimensions of the RFA lesion produced by the ablation procedure in these patients.
OUTLINE: Patients undergo intraoperative radiofrequency tumor ablation over 10-15 minutes for each tumor immediately followed by tumor resection.
PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of malignant non-small cell lung cancer (NSCLC)
- •Intraoperative needle biopsy confirmation allowed
- •Resectable disease (stage I or II)
- •All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection
- •Medically fit to undergo lung resection
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior or concurrent biologic therapy
- •Chemotherapy:
- •No prior or concurrent chemotherapy
- •Endocrine therapy:
- •No prior or concurrent endocrine therapy
- •Radiotherapy:
- •No prior or concurrent radiotherapy
- •See Disease Characteristics
- •No other prior therapy for NSCLC
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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