RTOG-1308

Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC

Principal Investigator

Zhongxing Liao, MD

Status

Disease Site

Lung [LU] Non-small Cell Lung Cancer

Phase

III

Developmental Therapeutics

No

Primary Objective

To compare the overall survival (OS) in patients with stage II-IIIB NSCLC after image guided, motion-managed photon radiotherapy (Arm 1) or after image guided, motion-managed proton radiotherapy (Arm 2) both given with concurrent platinum- based chemotherapy.

Patient Population

Histologically or cytologically proven diagnosis of NSCLC. Clinical AJCC (7^th ed.) stage II-IIIB medically non-operable disease, or surgically unresectable disease, or patients who refuse surgery; patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible.  Patients who received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are allowed.  Patients with history of Stage I-II disease already treated with surgery (no specific time limitation) or surgery and chemotherapy. are allowed.  Patients who had tumor recurrence after surgery are allowed provided they are considered candidates for chemoradiation therapy (must have re-stage II-III) with curative intention by the treating physician.

Target Accrual

560