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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00039507
First received: June 6, 2002
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: conventional surgery
Procedure: radiofrequency ablation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Pilot Study: Radiofrequency Ablation Of Resectable Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Study Start Date: June 2002
Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039507

Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Walter J. Scott, MD, FACS Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00039507     History of Changes
Other Study ID Numbers: CDR0000069389, P30CA006927, FCCC-02007, NCI-G02-2079
Study First Received: June 6, 2002
Last Updated: February 11, 2010
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
stage I non-small cell lung cancer
stage II non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014