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dc.contributor.authorHoppe, B.S.
dc.contributor.authorNichols, R.C.
dc.contributor.authorMohindra, P.
dc.date.accessioned2020-05-18T19:43:54Z
dc.date.available2020-05-18T19:43:54Z
dc.date.issued2020
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85084234539&doi=10.1016%2fj.ijrobp.2020.03.015&partnerID=40&md5=3a2c404f3ad49e7c313ce598d57ddddb
dc.identifier.urihttp://hdl.handle.net/10713/12767
dc.description.abstractPurpose: We report the safety data from the first multicenter phase 1 trial investigating the use of hypofractionated proton therapy with concurrent chemotherapy for patients with stage II or III non-small cell lung cancer. Methods and Materials: From 2013 through 2018, patients with newly diagnosed stage II or III non-small cell lung cancer were enrolled in a multicenter phase 1 clinical trial evaluating concurrent chemotherapy with increasing dose-per-fraction proton therapy. This was a stepwise 5 + 2 dose-intensification protocol with the following dose arms: (1) 2.5 GyRBE per fraction to 60 GyRBE; (2) 3.0 GyRBE per fraction to 60 GyRBE; (3) 3.53 GyRBE per fraction to 60.01 GyRBE; and (4) 4.0 GyRBE per fraction to 60 GyRBE. A dose arm was considered tolerable if no radiation therapy-attributable severe adverse event (SAE) occurred within 90 days of treatment among 5 patients enrolled on the arm or if 1 SAE occurred among 7 patients enrolled. Dose constraints to the heart, brachial plexus, and spinal cord were more conservative at higher doses per fraction. Results: The study closed early because of slow accrual and competing enrollment in NRG 1308 before accrual was met, with no maximum tolerated dose identified. Eighteen patients were treated, including 5 patients on arms 1 and 2, 7 patients on arm 3, and 1 patient on arm 4. Two SAEs occurred among 7 patients treated at 3.53 GyRBE per fraction; however, per outside expert review, both were attributed to chemotherapy and unrelated to radiation therapy. Conclusions: Hypofractionated proton therapy delivered at 2.5 to 3.53 GyRBE per fraction to a dose of 60 GyRBE with concurrent chemotherapy has an acceptable toxicity profile. Further exploration of this regimen is warranted on a phase 2 clinical trial. 2020 The Author(s)en_US
dc.description.sponsorshipThis research was made possible through the support of the James E. Lockwood, Jr. Professorship.en_US
dc.description.urihttps://doi.org/10.1016/j.ijrobp.2020.03.015en_US
dc.language.isoen_USen_US
dc.publisherElsevier Inc.en_US
dc.relation.ispartofInternational Journal of Radiation Oncology Biology Physics
dc.subjectconcurrent therapiesen_US
dc.subject.meshCarcinoma, Non-Small-Cell Lungen_US
dc.subject.meshProton Therapyen_US
dc.subject.meshDrug Therapyen_US
dc.titleHypofractionated Proton Therapy with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Phase 1 Trial from the University of Florida and Proton Collaborative Groupen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.ijrobp.2020.03.015
dc.identifier.pmid32251754


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