Radiofrequency Ablation During Surgery in Treating Patients With Non-Small Cell Lung Cancer

Pilot Study: Radiofrequency Ablation Of Resectable Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: conventional surgery; Procedure: radiofrequency ablation

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Age:

• Over 18

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• 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

Surgery:

• See Disease Characteristics

Other:

• No other prior therapy for NSCLC

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Walter J. Scott, MD, FACS, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Study Completion (Actual): February 1, 2004

Study Registration Dates

• First Submitted: June 6, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): February 12, 2010
• Last Update Submitted That Met QC Criteria: February 11, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CDR0000069389; P30CA006927 (U.S. NIH Grant/Contract); FCCC-02007; NCI-G02-2079