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

NCT ID: NCT00039507

Last Updated: 2010-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-02-29

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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conventional surgery

Intervention Type PROCEDURE

radiofrequency ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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:

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Principal Investigators

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Walter J. Scott, MD, FACS

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FCCC-02007

Identifier Type: -

Identifier Source: secondary_id

NCI-G02-2079

Identifier Type: -

Identifier Source: secondary_id

CDR0000069389

Identifier Type: -

Identifier Source: org_study_id

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