Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: High-Dose 3-Dimensional Conformal Radiation Therapy in Treating Patients With Inoperable Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

Summary: RATIONALE: Using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue.
  PURPOSE: This phase I trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage I, stage II, or stage IIIA non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage I, II, or IIIA non-small cell lung cancer who are treated according to the total lung volume irradiated.
  -  Determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients.
  OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%).
  -  Stratum I: Patients undergo high-dose 3-dimensional (3-D) conformal radiotherapy 5 days a week for 6 weeks.
  -  Stratum II: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-7 weeks.
  -  Stratum III: Patients undergo high-dose 3-D conformal radiotherapy 5 days a week for 5.5-6.5 weeks.
  Cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-D conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity.
  Patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter.
  PROJECTED ACCRUAL: A total of 54-135 patients (18-45 per stratum) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed non-small cell lung cancer
  -  Medically inoperable stage I or II disease
  -  Stage III disease eligible provided the following are true:
  -  No supraclavicular node involvement
  -  No peripherally located lower lobe tumor AND contralateral upper mediastinal node involvement
  -  No distant metastasis
  -  No malignant pleural or pericardial effusion
  PATIENT CHARACTERISTICS:
  Age
  -  Not specified
  Performance status
  -  WHO 0-2
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Cardiovascular
  -  No prior myocardial infarction
  -  No prior complete bundle branch block
  -  No other prior cardiovascular disease resulting in New York Heart Association class III or IV heart disease
  -  No clinically significant cardiac arrhythmias
  -  No congestive heart failure
  Pulmonary
  -  FEV_1 at least 1.2 L OR
  -  DLCO at least 60%
  Other
  -  No other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix
  -  No intractable or uncontrolled infection
  -  No psychological, familial, social, or geographical condition that would preclude study compliance and follow-up
  -  Able to tolerate a course of radiotherapy
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  At least 3 weeks since prior chemotherapy
  -  No prior anthracyclines
  -  No concurrent chemotherapy
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  No prior radiotherapy to the chest area
  Surgery
  -  No prior therapeutic surgery to the chest area
  Other
  -  No other prior therapy to the chest area

Relevance to patient case: not relevant