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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Radiation: radiation therapy; Procedure: radiofrequency ablation

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency Ablation with External Beam Radiation; Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy	Radiation: radiation therapy; Procedure: radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two Year Progression Free Survival Rate	the number of patients surviving progression-free at two years.	2 years

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: William Blackstock, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2007
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: July 10, 2007
• First Submitted That Met QC Criteria: July 10, 2007
• First Posted (Estimate): July 11, 2007

Study Record Updates

• Last Update Posted (Actual): May 8, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung; stage I non-small cell lung cancer; adenosquamous cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CDR0000555009; CCCWFU 62306 (Other Identifier: CCCWFU); IRB00001334 (Other Identifier: WFUHS IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes