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N/A N=13 Treatment

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

Lung Cancer

Enrolled (actual)
13
Serious AEs
66.7%
Results posted
Mar 2013
Primary outcome: Primary: Two Year Progression Free Survival Rate — 8 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
radiofrequency ablation (Procedure); radiation therapy (Radiation)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Mar 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Two Year Progression Free Survival Rate
8

Summary

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00499447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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