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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.

Primary Objective:
To compare the overall survival in patients with stage II-IIIC inoperable node-positive 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.

Protocol Number: 032501
Phase: Phase III
Applicable Disease Sites: Lung
Principal Investigator: Salma Jabbour
Scope: National
Participating Institutions:
  • RWJBarnabas Health
    • Robert Wood Johnson University Hospital, Somerset
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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