A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
Proton radiation will be delivered daily Monday through Friday for 5 weeks. Study therapy
will be give as an outpatient at the Francis H. Burr Proton Center at Massachusetts General
During the weeks that subjects receive radiation, they will also receive 2 cycles of
chemotherapy. Each cycle will last 28 days.
Cisplatin will be give as an IV infusion over 30-60 minutes or 1-2 hours on Days 1 and 8 of
Cycles 1 and 2.
Etoposide will be given as an IV infusion over 60 minutes on Days 1, 2, 3, 4, 5 of Cycles 1
After radiation and 2 cycles of chemotherapy are completed, subjects may have surgery to
remove their tumor.
Following surgery, subjects may receive another 2 cycles of chemotherapy (Cycles 3 and 4).
Each cycles lasts 21 days. Cisplatin is given on Day 1. Etoposide is given on Days 1, 2, and
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish the MTD of a proton beam-based regimen consisting of 25 fractions, together with concurrent standard cisplatin and etoposide chemotherapy followed by surgery +/- adjuvant chemotherapy for Stage III NSCLC, and to describe post-treatment surgical complications and treatment toxicity using CTCAE v4.0
Henning Willers, MD
Massachusetts General Hospital
United States: Institutional Review Board
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