A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

January 31, 2038

Conditions
Lung Neoplasms
Interventions
RADIATION

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."

Trial Locations (6)

21201

Maryland Proton Treatment Center, Baltimore

23666

Hampton University Proton Therapy Institute, Hampton

32206

University of Florida Proton Therapy Institute, Jacksonville

60555

Northwestern Medicine Chicago Proton Center, Warrenville

73142

Oklahoma Proton Center, Oklahoma City

08873

Princeton ProCure Management LLC, Somerset

All Listed Sponsors
lead

Proton Collaborative Group

NETWORK

NCT01770418 - A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter