Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Summary: RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
  PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.
  Secondary
  -  Determine the toxicities of this regimen in these patients.
  -  Determine the rates of regional and distant disease recurrence in these patients.
  -  Determine the progression-free and overall survival of patients treated with this regimen.
  -  Determine the changes in pulmonary function after treatment in these patients.
  -  Assess the quality of life of patients after treatment.
  OUTLINE: This is a multicenter, prospective study.
  Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.
  Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year.
  After completion of study treatment, patients are followed periodically for 5 years.
  PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  -  Stage I or II peripheral disease
  -  T1, N0, M0
  -  T2 (≤ 5 cm), N0, M0
  -  T3 (≤ 5 cm, chest wall primary tumor only), N0, M0
  -  No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement
  -  No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)
  -  Hilar or mediastinal lymph nodes ≤ 1 cm considered N0
  -  Any of the following primary cancer types:
  -  Squamous cell carcinoma
  -  Adenocarcinoma
  -  Large cell carcinoma
  -  Bronchioloalveolar cell carcinoma
  -  Non-small cell carcinoma not otherwise specified
  -  Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)
  -  Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed
  -  If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen
  -  Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs
  -  No ataxia telangiectasia
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Not pregnant or nursing
  -  Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)
  -  No active systemic, pulmonary, or pericardial infection
  -  No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.
  -  Previous diagnosis of cancer that is free of recurrence and metastases for ≥ 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)
  PRIOR CONCURRENT THERAPY:
  -  No prior radiotherapy to the area of the primary tumor
  -  No prior or concurrent chemotherapy or immunotherapy for this tumor

Relevance to patient case: not relevant