Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

Summary: This pilot clinical trial studies the side effects of cryotherapy (cryoablation [CA]) in treating patients with lung cancer. Cryotherapy kills cancer cells by freezing them.

Detailed description: PRIMARY OBJECTIVES:
  I. Assess the initial safety of the CA for lung tumors less than or equal to 3.5 cm in size including acute toxicity (30 days).
  SECONDARY OBJECTIVES:
  I. Estimate local control.
  II. To assess physical function for this cohort of patients.
  III. To evaluate the impact of treatment on generic and disease-specific quality of life.
  IV. To obtain pilot data useful for the design of a subsequent phase II or randomized phase II trial.
  V. Evaluate changes in pulmonary function at 3 months.
  OUTLINE:
  Patients undergo computed tomography (CT)-guided CA
  After completion of study treatment, patients are followed up at 1 week and 1, 3, 6, 12, 24, 36, 48, and 60 months.

Eligibility: Inclusion Criteria:
  -  Patients with American Joint Committee on Cancer (AJCC) seventh edition metastatic carcinoma or sarcoma involving the lungs or pleura.
  -  Pathologic diagnosis of stage 4 cancer prior to enrollment by biopsy or on imaging with known (biopsied) primary disease
  -  The target lesion is determined (by CT or magnetic resonance imaging [MRI] images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures
  -  Maximum number of lesions per patient will be 5 total (a maximum of 3 on either the right or left side and 2 lesions on the respective contralateral side)
  -  Of these, any lesion not treated with cryoablation will be planned to be treated with radiotherapy or radiofrequency ablation, such that all known active pulmonary disease is planned to be treated with a definitive local therapy
  -  If treatment of both lungs is to occur by cryoablation, these treatments must be separated by at least one week
  -  The lesion(s) treated with cryoablation may be intrapulmonary or pleural and must be =< 3.5 cm in greatest dimension
  -  All patients are required to have been evaluated either in consultation with a radiation oncologist or at least in a multi-disciplinary tumor conference to ensure that all local therapy options are appropriately considered for each patient
  -  Performance Status 0-2 (Eastern Cooperative Oncology Group [ECOG]); Karnofsky Performance Scale >= 60
  -  Life expectancy > 3 months
  -  Clinically suitable for cryoablation procedure as determined by the treating physician
  -  Platelet count > 50,000/mm^3 within 60 days prior to study registration
  -  International normalized ratio (INR) < 1.5 within 60 days prior to study registration
  -  Absolute neutrophil count (ANC) < 1000 within 21 days prior to study registration
  -  A signed study specific consent form is required
  Exclusion Criteria:
  -  Primary lung cancer
  -  Unable to lie flat or has respiratory distress at rest
  -  Uncontrolled coagulopathy or bleeding disorders
  -  Evidence of active systemic, pulmonary, or pericardial infection
  -  Pregnant, nursing or wishes to become pregnant during the study
  -  Debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up
  -  Currently participating in other experimental studies that could affect the primary endpoint

Relevance to patient case: not relevant