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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039507
• Other study ID #: CDR0000069389
• Secondary ID: P30CA006927FCCC-
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: February 11, 2010
• Start date: June 2002
• Est. completion date: February 2004

Study information

• Verified date: February 2010
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• conventional surgery

• radiofrequency ablation

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,