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A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography



- 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).


- To determine the acute and late toxicity of combining RFA with external-beam radiation

- 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

- 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

- 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.


- 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

- 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



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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two Year Progression Free Survival Rate

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Hollins Clark, MD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096