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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

conventional surgery

radiofrequency ablation

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fox Chase Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00039507

First Posted

June 6, 2002

Last Updated

February 11, 2010

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00039507

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

stage I non-small cell lung cancer, stage II non-small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

Intervention Type

Procedure

Intervention Name(s)

radiofrequency ablation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter J. Scott, MD, FACS

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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