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Completed

NCT Number: NCT00039507

Radiofrequency Ablation During Surgery in Treating Patients With 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional surgery

Procedure

Radiofrequency ablation

Procedure

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Jan 27, 2003
Registry last updated
Feb 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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