Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to determine whether an accelerated course of hypofractionated
      radiation therapy with daily image guidance and motion assessment/control will allow more
      effective treatment of poor performance status patients with stage II-III NSCLC, who would
      benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per
      fraction).
    

Detailed description: 
      The study is designed to determine whether an accelerated course of hypofractionated
      radiation therapy with daily image guidance and motion assessment/control will allow more
      effective treatment of poor performance status patients with stage II-III NSCLC, who would
      benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per
      fraction). Poor performance status patients can be a heterogeneous group, with tumor-related
      factors, other co-morbidities, or advanced age placing patients in the category. These
      patients have traditionally been underrepresented in clinical trials, and thus no prospective
      study has evaluated the efficacy of other radiotherapy dose fractionations in these patients.
      One phase III trial of "poor-risk" locally advanced NSCLC (RTOG 93-04) included just over 40%
      Karnofsky performance status 60-70 patients and showed median survival times of 9.5 and 10.3
      months with 60Gy of conventional radiation therapy alone or with recombinant β-interferon
      [18]. 1 year overall survival was just 44% in these patients.

      This study includes randomization to two arms. Arm A (experimental arm) will include IGRT, 60
      Gy in 15 fractions (3 weeks). Arm B will include conventional radiation, 60-66 Gy in 30-33
      fractions (6 weeks) with optional concurrent with carboplatin/taxol .

      The experimental arm dose for this trial is based on a dose escalation trial at University of
      Texas Southwestern evaluating the maximum tolerated dose of hypofractionated IGRT in this
      patient population (Phase I study IRB #072010-050). Doses were escalated from 3 Gy per
      fraction (total dose 45 Gy) to 4 Gy per fraction (total dose 60 Gy) and evaluation for
      treatment related toxicity was being performed. Critical structure dose constraints will be
      expressed as organ dose-volume limits, with limits formulated with the approval of the study
      investigators using known tolerance data, radiobiological conversion models, and norms used
      in current practice at academic centers [27].

      Randomization Schema:

      Patients will be allocated to the treatment using a randomized permuted block within strata
      to balance for patient factors other than institution. The stratifying variables are Zubrod
      performance status (2 vs. > 2) and stage (II vs. III).
    

Intervention name(s): Radiation Therapy; Conventional radiation
Intervention type(s): Radiation; Radiation
Intervention description(s): Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks; Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: non-small cell lung cancer; Stages II or III non-small cell lung cancer