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CompletedNot applicableNCT00499447
Official study title

Radiofrequency Ablation and External-Beam Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Study summary

RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedradiofrequency ablation and radiation therapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Procedure: radiofrequency ablation; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Radiation therapy→Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • DISEASE CHARACTERISTICS:
  • Histologically confirmed non-small cell lung cancer
  • Cytology or biopsy-proven disease
  • Stage IA (T1N0M0) or select stage IB (T2N0M0 because of visceral pleural involvement or size ≥ 3.0 cm)
  • Tumor size ≤ 3.5 cm
  • No bronchioloalveolar carcinoma
  • Node-negative patients will have hilar or mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on fludeoxyglucose F 18 (FDG)-PET in those areas
  • Patients with \> 1.5 cm lymph nodes and clinically suspicious FDG-PET uptake will still be eligible if directed tissue biopsy or needle aspiration of abnormally identified area are negative for cancer
  • Patients with \> 1.5 cm and \< 2.0 cm lymph nodes and no clinically suspicious FDG-PET uptake in those areas will still be eligible
  • All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to comorbid conditions
  • CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion must be determined to be in a location where radiofrequency ablation is technically achievable based on the proximity of adjacent organs and structures
  • Any patient with suspected M1 disease based on pre-treatment PET-CT imaging should have biopsy if possible
  • If the biopsy is positive, the patient should be treated as per the clinician's preference off of this protocol
  • If the biopsy is negative and representative of the lesion in question then the patient may be treated as per this protocol
  • If the biopsy is non-diagnostic, consideration should be given to repeat biopsy
  • If the repeat biopsy remains non-diagnostic or a biopsy is not feasible than the patient will not be eligible for this protocol and should be treated per the clinician's preference PATIENT CHARACTERISTICS:
  • ECOG performance status 0-2
  • Women of childbearing potential must have a negative pregnancy test
  • Fertile women must use effective contraception
Reasons someone may not be able to joinExclusion criteria
  • History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA level \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to study entry
  • Pregnant or lactating women PRIOR CONCURRENT THERAPY:

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 8, 2019. Always confirm current availability with the study team.

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