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A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
Sponsor: Proton Collaborative Group
Summary
The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2013-03
Completion Date
Not specified
Last Updated
2025-09-09
Healthy Volunteers
No
Conditions
Interventions
Radiation with Concurrent Chemotherapy
RADIATION: Proton Radiotherapy Dose Level 1: 60 Gy (RBE) at 2.5 Gy(RBE) per fraction x 24 fractions Dose Level 2: 60 Gy (RBE) at 3 Gy (RBE) per fraction x 20 fractions Dose Level 3: 60.01 Gy (RBE) at 3.53 Gy (RBE) per fraction x 17 fractions Dose Level 4: 60 Gy (RBE) at 4 Gy (RBE) per fraction x 15 fractions CONCURRENT CHEMOTHERAPY: Paclitaxel at a dose of 45 mg/m2 and Carboplatin at a dose of AUC 2 mg/min/ml (a total of 3-5 weekly doses) OR Cisplatin 50mg/m2 days 1, 8, 29, and 36 and Etoposide 50mg/m2 days 1-5, 29-33. For non squamous histology, Carboplatin AUC 5 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days OR Cisplatin 75 mg/m2 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days. Adjuvant chemotherapy is optional.
Locations (6)
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
Maryland Proton Treatment Center
Baltimore, Maryland, United States
Princeton ProCure Management LLC
Somerset, New Jersey, United States
Oklahoma Proton Center
Oklahoma City, Oklahoma, United States
Hampton University Proton Therapy Institute
Hampton, Virginia, United States