This phase I trial studies the side effects and best dose of hypofractionated proton beam radiation therapy when given together with paclitaxel and carboplatin in treating patients with stage II-III non-small cell lung cancer. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Giving proton beam radiation therapy at higher doses over fewer days (hypofractionation) may improve local control of the tumor. Giving hypofractionated proton beam radiation therapy with chemotherapy may be a better treatment for non-small cell lung cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Washington University School of Medicine
St Louis, Missouri, United States
Maximum tolerated dose (MTD) of hypofractionated proton beam therapy (PBT) with chemotherapy
Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. The MTD will be chosen as the dose that yields a posterior estimate of toxicity closest to 20% while being between 15% and 25%. Dose limiting toxicity will be defined as toxicity that occurs within 6 months from the start of treatment, is possibly, probably or definitely related to treatment, and is related to the following Grade 3-5 pericardial effusion, pericarditis, restrictive cardiomyopathy, hemorrhage (pulmonary or upper respiratory), excluding nose, larynx, or pharynx, brachial plexopathy, laryngeal nerve dysfunction, myelitis, phrenic nerve dysfunction , atelectasis (grade 4-5 only), pulmonary fistula, hypoxia (provided grade 3 is worse than baseline), obstruction/stenosis of the airway, pleural effusion, pneumonitis, pulmonary fibrosis Grade 4-5 dysphagia, esophagitis, esophageal fistula, obstruction, perforation, stricture/stenosis, ulcer, and hemorrhage Grade 4-5 skin Any grade 5
Time frame: Up to 6 months
Incidence of acute toxicities
Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. Adverse events will be tabulated by type and grade.
Time frame: Up to 6 months
Incidence of late toxicities as defined
Common Terminology Criteria for Adverse Events version 4 (CTCAE) will be used. Adverse events will be tabulated by type and grade.
Time frame: Up to 1 year
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