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: June 18, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: William Blackstock, 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: June 18, 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 August 28, 2014