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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00499447
First received: July 10, 2007
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Procedure: radiofrequency ablation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Two Year Progression Free Survival Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    the number of patients surviving progression-free at two years.


Secondary Outcome Measures:
  • Rate of Acute and Late Treatment-related Toxicity (Per CTCAE, v3.0) Related to Specific Symptoms [ Time Frame: two years ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: May 2007
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499447

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Hollins Clark, MD, MS Comprehensive Cancer Center of Wake Forest University
Study Chair: James J. Urbanic, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00499447     History of Changes
Other Study ID Numbers: CDR0000555009, CCCWFU 62306, IRB00001334
Study First Received: July 10, 2007
Results First Received: January 25, 2013
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
stage I non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
large cell lung cancer
squamous cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014