Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The study is designed to determine whether daily image guidance and motion assessment/control
      will allow treatment of poor performance status patients with stage II-IV NSCLC, who would
      benefit from local therapy, with an accelerated course of hypofractionated radiation therapy.
    

Detailed description: 
      Subjects for this study will be enrolled by the Moncrief Radiation oncology Department at the
      Simmons Cancer Center.

      Primary objective: To escalate the dose of accelerated, hypofractionated, image-guided
      conformal radiotherapy to a potent tumorcidal dose without exceeding the maximum tolerated
      dose in treatment of stage ii-iV nSCLC in patients with poor performance status.

      Secondary objectives: To evaluate local regional tumor control and overall survival in
      patients with stage ii-iV nSCLC and poor performance status treated with accelerated,
      hypofractionated, image-guided conformal radiotherapy.

      Schema

      number of patients between 7-45 (depending on tolerance)

      Patients in each dose cohort will all be treated as a single group for dose escalation. The
      starting dose will be 3.33 Gy per fraction for 15 fractions (total dose 50 Gy). Subsequent
      cohorts of patients will receive a higher dose per fraction as follows:

      Cohort No. Fractions Dose per fraction (Gy) Total Dose (Gy) No. Patients

        1. 15 3.33 50 7-15

        2. 15 3.67 55 7-15

        3. 15 4.00 60 7-15

      Minimum waiting periods will be assigned between each dose cohort to observe toxicity.

      Screening Procedures

      each study participant will have the following exams, tests or procedure to help determine if
      they are qualified to be in this study:

      Within 8 weeks of enrollment :

        -  Computed tomographic (CT) with contrast of the lung and upper abdomen. a CT done in
           conjunction with a Positron emission Tomography (PeT) scan is satisfactory as long as
           the images are of adequate quality to be interpreted by a radiologist.

        -  an MRi of the brain with contrast (or CT if MRi is medically contraindicated).

        -  Complete Blood Count (CBC) with differential

        -  Charleston Comorbidity index completion

      Within 3 days prior to radiotherapy: urine or serum pregnancy test in females of
      child-bearing capacity.

      Within 12 weeks of enrollment:

      * Pulmonary function tests including spirometry for forced expiratory volume in 1 second
      (FeV-1), diffusing capacity (DLCo), and arterial blood gas (Pao-2).

      Prior to enrollment on the study: Tissue biopsy or cytology confirming non-small cell lung
      cancer.

      Treatment Protocol treatment must begin within 4 weeks after patient registration to the
      trial. Patients will receive 15 fractions of radiation. Total dose will depend on the dose
      cohort of the study (see schema). The starting dose level will be 3.33 Gy per fraction for 15
      fractions (total dose [?] 50 Gy).

      Patients must not receive other concomitant antineoplastic therapy (including standard
      fractionated radiotherapy to the chest, chemotherapy, biological therapy, vaccine therapy,
      and surgery) within a week prior to, during, or within one week after completing
      hypofractionated image-guided radiation therapy on protocol.

      Follow-up Patients will be followed until death.
    

Intervention name(s): Image-Guided Radiation Therapy
Intervention type(s): Radiation
Intervention description(s): Radiotherapy to a potent tumorcidal dose
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment