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ACTIVE NOT RECRUITING
NCT01770418
PHASE1/PHASE2

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

Sponsor: Proton Collaborative Group

View on ClinicalTrials.gov

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

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