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CompletedNCT00499447Updated May 8, 2019Results posted

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

An interventional study of radiofrequency ablation and radiation therapy in Lung Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-05-08.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 120 Years
Sex
All
01

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.

Read the detailed description

OBJECTIVES:

Primary

  • To determine progession free survivial rates in patients with inoperable stage IA and select stage IB non-small cell lung cancer treated with external-beam radiation therapy and radiofrequency ablation (RFA).

Secondary

  • To determine the acute and late toxicity of combining RFA with external-beam radiation therapy.
  • To determine the patterns of failure at time of first relapse.
  • To determine the rate of overall survival at 1 and 2 years after treatment.
  • To evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior to RFA to predict local control and time to progression.
  • To measure post RFA/simulation (treatment planning) PET max and peak SUV's and correlate this data with local control at 1 and 2 years.
  • To evaluate the ability of peak and max SUV's for fludeoxyglucose F 18 obtained shortly after radiotherapy (post-treatment) to predict local control and time to progression.
  • To evaluate PET-CT data and its utility in guiding radiation therapy treatment planning.
  • To explore the use of dual time point imaging PET data obtained to predict local control and also to differentiate between recurrence versus inflammation when applicable.
  • To assess physical function as a prognostic measure, and to determine the impact of treatment on physical function.
  • To evaluate the impact of treatment on generic and disease-specific quality of life.

OUTLINE: Patients undergo fludeoxyglucose F18 positron emission tomography (FDG-PET) and CT scan at baseline. Patients then undergo radiofrequency ablation (RFA). Beginning within 5 weeks after completion of RFA, patients undergo external-beam radiation therapy once daily, 5 days a week, for 5-6 weeks. FDG-PET/CT scan is repeated 3-4 weeks after RFA and 12-16 weeks after completion of external-beam radiation therapy.

Quality of life is assessed at baseline, during treatment, and at 16 weeks and at 1 year after completion of treatment.

After completion of study treatment, patients are followed periodically for 2 years.

02

Conditions studied

  • Lung Cancer

Keywords

  • stage I non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 13 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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:

  • Inclusion Criteria:

    • ECOG performance status 0-2
    • Women of childbearing potential must have a negative pregnancy test
    • Fertile women must use effective contraception
  • Exclusion 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:

  • Exclusion Criteria:

    • Previous chest radiation to the lung or mediastinum
    • Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:

      • Radiotherapy
      • Radiofrequency ablation
      • Other antineoplastic interventional radiology techniques
      • Chemotherapy
      • Biological therapy
      • Vaccine therapy
      • Surgery

        • Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowed
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Radiofrequency Ablation with External Beam Radiation

    Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy

    Procedure: radiofrequency ablation · Radiation: radiation therapy

Interventions

  • Procedureradiofrequency ablation
  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Two Year Progression Free Survival Rate

    the number of patients surviving progression-free at two years.

    Time frame: 2 years

07

Results

Posted Mar 1, 2013
Limitations and caveats
adverse events were tracked in two cycles, one during treatment and one longer term

Participant flow

Participants were recruited from the Radiation Oncology Clinic at the Comprehensive Cancer Center of Wake Forest University.

Participant flow — Overall Study
MilestoneRadiofrequency Ablation Combined With External
Started13
Completed13
Not completed0

Outcome measures

PrimaryTwo Year Progression Free Survival Rate

the number of patients surviving progression-free at two years.

Time frame:
2 years
Reported as:
Number · participants
Two Year Progression Free Survival Rate
participantsRadiofrequency Ablation Combined With External
Two Year Progression Free Survival Rate8

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Radiofrequency Ablation Combined With External—8/12 (66.7%)12/12 (100%)
Most frequent serious events
Most frequent serious events
EventRadiofrequency Ablation Combined With External
Carbon monoxide diffusionInvestigations4/12
LymphopeniaInvestigations4/12
decreased forced expiratory volumeRespiratory, thoracic and mediastinal disorders3/12
hyperglycemiaInvestigations2/12
DyspneaRespiratory, thoracic and mediastinal disorders1/12
Lung infectionInfections and infestations1/12
BurnGeneral disorders1/12
Most frequent other events
Showing 10 of 62
Most frequent other events
EventRadiofrequency Ablation Combined With External
decreased forced expiratory volumeRespiratory, thoracic and mediastinal disorders9/12
Low HemoglobinInvestigations8/12
Carbon monoxide diffusionInvestigations8/12
hyperglycemiaInvestigations8/12
CoughRespiratory, thoracic and mediastinal disorders6/12
PneumothoraxRespiratory, thoracic and mediastinal disorders6/12
FatigueGeneral disorders5/12
Pain: Chest wallGeneral disorders5/12
DyspneaReproductive system and breast disorders4/12
Pneumonitis/pulmonary infiltratesRespiratory, thoracic and mediastinal disorders4/12

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Radiofrequency Ablation Combined With External
<=18 years0
Between 18 and 65 years4
>=65 years9
Age, Continuous
Age, Continuous(years)Radiofrequency Ablation Combined With External
Mean70.5 ± 9.7
Sex: Female, Male
Sex: Female, Male(Participants)Radiofrequency Ablation Combined With External
Female4
Male9
Region of Enrollment
Region of Enrollment(participants)Radiofrequency Ablation Combined With External
United States13
08

Study locations

1 site
  • Wake Forest University Comprehensive Cancer Center
    Winston-Salem, North Carolina 27157-1096, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00499447
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 11, 2007
Start date
May 2007
Primary completion
Mar 2010
Completion
Mar 2010
Results posted
Mar 1, 2013
Last update
May 8, 2019

Study contacts

William Blackstock, MD
study chair · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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