Patient case: 54-year-old female with non-small cell lung cancer; genetic feature: EGFR (D770N)

Clinical trial: Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction

Summary: RATIONALE: Specialized 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: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction.
  -  Determine the short-term and long-term toxicity of this regimen in these patients.
  -  Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen.
  -  Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients.
  OUTLINE: This is a dose-escalation, multicenter study.
  Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
  Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
  Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
  -  Squamous cell carcinoma
  -  Basaloid carcinoma
  -  Adenocarcinoma
  -  Bronchoalveolar carcinoma
  -  Adenosquamous carcinoma
  -  Large cell carcinoma
  -  Large cell neuroendocrine carcinoma
  -  Giant cell carcinoma
  -  Sarcomatoid carcinoma
  -  Non-small cell carcinoma not otherwise specified
  -  Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
  -  No metastatic disease or hilar or mediastinal lymphadenopathy
  -  Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
  -  No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum
  -  Poor surgical risk, as defined by 1 of the following:
  -  High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
  -  Pulmonary dysfunction indicated by one or more of the following:
  -  FEV_1 less than 40% of predicted
  -  DLCO less than 50% of predicted
  -  Oxygen dependent
  -  Chronic PaCO_2 greater than 45 mm Hg
  -  VO_2 less than 15 mL/kg/min
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  0-2
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No weight loss of more than 10% within the past 6 months
  -  No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer
  Chemotherapy:
  -  No prior chemotherapy for NSCLC
  Radiotherapy:
  -  No prior chest radiotherapy

Relevance to patient case: not relevant