NRG-LU008: Phase III Prospective Randomized Trial Of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed By Concurrent Mediastinal Chemoradiation For Locally Advanced Non-Small Cell Lung Cancer
Objective
Primary Objectives: To compare the overall survival in patients with stage II-IIIC inoperable nodepositive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after image guided, motion-managed stereotactic body radiation therapy (SBRT) to the primary tumor followed by conventionally fractionated radiotherapy to nodal metastases (Arm 2) both given with concurrent platinum-based chemotherapy. To compare progression-free survival between the experimental arm (Arm 2) and control arm (Arm 1).
Secondary Objectives: To compare objective response rate (as defined by RECIST v 1.1) between the experimental arm and control arm. To compare the rate of local control between the experimental arm and control arm. To compare patterns of failure (primary, locoregional, or distant) between the experimental arm and control arm. To compare changes in pulmonary function (FEV1 and DLCO assessed at randomization and at 6 and 12 months following completion of radiation therapy) between the experimental arm and control arm. To compare changes in quality of life and patient-reported outcomes assessed from pre-treatment to 3 months following radiation therapy of each treatment arm. To determine acute and late toxicity profiles of each treatment arm as measured by the CTCAEv5.
