Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the
      tumor and cause less damage to normal tissue.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic
      body radiation therapy and to see how well it works in treating patients with stage I
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT)
           in medically inoperable patients with centrally located stage I non-small cell lung
           cancer. (Phase I)

        -  To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)

      Secondary

        -  To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade 3
           that is possibly, probably, or definitely related to treatment and that occurs within 1
           year after the start of SBRT in these patients.

        -  To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of
           SBRT) in these patients.

        -  To estimate the local control and progression-free and overall survival rates in
           patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks [total of 5
      fractions (FX)] in the absence of disease progression or unacceptable toxicity.

      After completion of study therapy, patients are followed every 3 months for 2 years, then
      every 6 months for 2 years, then annually.
    

Intervention name(s): SBRT 40.0 Gy; SBRT 42.5 Gy; SBRT 45.0 Gy; SBRT 47.5 Gy; SBRT 50.0 Gy; SBRT 52.5 Gy; SBRT 55.0 Gy; SBRT 57.5 Gy; SBRT 60.0 Gy
Intervention type(s): Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation; Radiation
Intervention description(s): SBRT delivered in 5 fractions of 8.0 Gy/fraction over 1.5 to 2 weeks for a total of 40.0 Gy; SBRT delivered in 5 fractions of 8.5 Gy/fraction over 1.5 to 2 weeks for a total of 42.5 Gy; SBRT delivered in 5 fractions of 9.0 Gy/fraction over 1.5 to 2 weeks for a total of 45.0 Gy; SBRT delivered in 5 fractions of 9.5 Gy/fraction over 1.5 to 2 weeks for a total of 47.5 Gy; SBRT delivered in 5 fractions of 10.0 Gy/fraction over 1.5 to 2 weeks for a total of 50.0 Gy; SBRT delivered in 5 fractions of 10.5 Gy/fraction over 1.5 to 2 weeks for a total of 52.5 Gy; SBRT delivered in 5 fractions of 11.0 Gy/fraction over 1.5 to 2 weeks for a total of 55.0 Gy; SBRT delivered in 5 fractions of 11.5 Gy/fraction over 1.5 to 2 weeks for a total of 57.5 Gy; SBRT delivered in 5 fractions of 12.0 Gy/fraction over 1.5 to 2 weeks for a total of 60.0 Gy
Other intervention name(s): Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR); Stereotactic body radiation therapy (SBRT); Stereotactic ablative radiotherapy (SABR)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I non-small cell lung cancer