Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 10, 2007
June 18, 2014
May 2007
March 2010   (final data collection date for primary outcome measure)
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.
Time to local failure and local control at 1 and 2 years
Complete list of historical versions of study NCT00499447 on ClinicalTrials.gov Archive Site
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 ]
  • Rate of acute and late treatment-related toxicity (per CTCAE, v3.0) related to specific symptoms
  • Patterns of failure and overall survival at 2 years
  • Evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior to radiofrequency ablation (RFA) to predict local control and time to progression
  • Measure post RFA/simulation (treatment planning) PET max and peak SUV’s and correlate this data with local control at 1 and 2 years
  • Evaluate the ability of peak and max SUV for fludeoxyglucose F 18 obtained shortly after radiotherapy (post treatment) to predict local control and time to progression
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Procedure: radiofrequency ablation
  • Radiation: radiation therapy
Experimental: Radiofrequency Ablation with External Beam Radiation
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
Interventions:
  • Procedure: radiofrequency ablation
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
13
Not Provided
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00499447
CDR0000555009, CCCWFU 62306, IRB00001334
Yes
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: William Blackstock, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP