Literature DB >> 29735186

Comparing Intensity-Modulated Proton Therapy With Intensity-Modulated Photon Therapy for Oropharyngeal Cancer: The Journey From Clinical Trial Concept to Activation.

Steven J Frank1, Pierre Blanchard2, J Jack Lee3, Erich M Sturgis4, Merrill S Kies5, Mitchell Machtay6, Bhadrasain Vikram7, Adam S Garden8, David I Rosenthal8, G Brandon Gunn8, C David Fuller8, Katherine Hutcheson4, Stephen Lai4, Paul M Busse9, Nancy Y Lee10, Alexander Lin11, Robert L Foote12.   

Abstract

Intensity-modulated proton therapy minimizes the incidental irradiation of normal tissues in patients with head and neck cancer relative to intensity-modulated photon (x-ray) therapy and has been associated with lesser treatment-related toxicity and improved quality of life. A phase II/III randomized trial sponsored by the US National Cancer Institute is currently underway to compare deintensification treatment strategies with intensity-modulated proton therapy vs intensity-modulated photon (x-ray) therapy for patients with advanced-stage oropharyngeal tumors. After significant input from numerous stakeholders, the phase III portion of the randomized trial was redesigned as a noninferiority trial with progression-free survival as the primary endpoint. The process by which that redesign took place is described here.
Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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Year:  2018        PMID: 29735186      PMCID: PMC5942581          DOI: 10.1016/j.semradonc.2017.12.002

Source DB:  PubMed          Journal:  Semin Radiat Oncol        ISSN: 1053-4296            Impact factor:   5.934


  15 in total

1.  Intensity Modulated Proton Therapy Versus Intensity Modulated Photon Radiation Therapy for Oropharyngeal Cancer: First Comparative Results of Patient-Reported Outcomes.

Authors:  Terence T Sio; Huei-Kai Lin; Qiuling Shi; G Brandon Gunn; Charles S Cleeland; J Jack Lee; Mike Hernandez; Pierre Blanchard; Nikhil G Thaker; Jack Phan; David I Rosenthal; Adam S Garden; William H Morrison; C David Fuller; Tito R Mendoza; Radhe Mohan; Xin Shelley Wang; Steven J Frank
Journal:  Int J Radiat Oncol Biol Phys       Date:  2016-02-18       Impact factor: 7.038

2.  A multiple testing procedure for clinical trials.

Authors:  P C O'Brien; T R Fleming
Journal:  Biometrics       Date:  1979-09       Impact factor: 2.571

3.  Clinical Outcomes and Patterns of Disease Recurrence After Intensity Modulated Proton Therapy for Oropharyngeal Squamous Carcinoma.

Authors:  G Brandon Gunn; Pierre Blanchard; Adam S Garden; X Ronald Zhu; C David Fuller; Abdallah S Mohamed; William H Morrison; Jack Phan; Beth M Beadle; Heath D Skinner; Erich M Sturgis; Merrill S Kies; Kate A Hutcheson; David I Rosenthal; Radhe Mohan; Michael T Gillin; Steven J Frank
Journal:  Int J Radiat Oncol Biol Phys       Date:  2016-02-12       Impact factor: 7.038

4.  Dosimetric advantages of intensity-modulated proton therapy for oropharyngeal cancer compared with intensity-modulated radiation: A case-matched control analysis.

Authors:  Emma B Holliday; Esengul Kocak-Uzel; Lei Feng; Nikhil G Thaker; Pierre Blanchard; David I Rosenthal; G Brandon Gunn; Adam S Garden; Steven J Frank
Journal:  Med Dosim       Date:  2016-05-04       Impact factor: 1.482

5.  Patterns of disease recurrence following treatment of oropharyngeal cancer with intensity modulated radiation therapy.

Authors:  Adam S Garden; Lei Dong; William H Morrison; Erich M Stugis; Bonnie S Glisson; Steven J Frank; Beth M Beadle; Gary B Gunn; David L Schwartz; Merill S Kies; Randal S Weber; K Kian Ang; David I Rosenthal
Journal:  Int J Radiat Oncol Biol Phys       Date:  2012-09-11       Impact factor: 7.038

Review 6.  Survivorship and Quality of Life in Head and Neck Cancer.

Authors:  Jolie Ringash
Journal:  J Clin Oncol       Date:  2015-09-08       Impact factor: 44.544

7.  Identification of Patient Benefit From Proton Therapy for Advanced Head and Neck Cancer Patients Based on Individual and Subgroup Normal Tissue Complication Probability Analysis.

Authors:  Annika Jakobi; Anna Bandurska-Luque; Kristin Stützer; Robert Haase; Steffen Löck; Linda-Jacqueline Wack; David Mönnich; Daniela Thorwarth; Damien Perez; Armin Lühr; Daniel Zips; Mechthild Krause; Michael Baumann; Rosalind Perrin; Christian Richter
Journal:  Int J Radiat Oncol Biol Phys       Date:  2015-04-23       Impact factor: 7.038

8.  Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy.

Authors:  Johannes A Langendijk; Patricia Doornaert; Irma M Verdonck-de Leeuw; Charles R Leemans; Neil K Aaronson; Ben J Slotman
Journal:  J Clin Oncol       Date:  2008-08-01       Impact factor: 44.544

9.  Intensity-modulated proton beam therapy (IMPT) versus intensity-modulated photon therapy (IMRT) for patients with oropharynx cancer - A case matched analysis.

Authors:  Pierre Blanchard; Adam S Garden; G Brandon Gunn; David I Rosenthal; William H Morrison; Mike Hernandez; Joseph Crutison; Jack J Lee; Rong Ye; C David Fuller; Abdallah S R Mohamed; Kate A Hutcheson; Emma B Holliday; Nikhil G Thaker; Erich M Sturgis; Merrill S Kies; X Ronald Zhu; Radhe Mohan; Steven J Frank
Journal:  Radiother Oncol       Date:  2016-06-21       Impact factor: 6.280

10.  Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data.

Authors:  Stefan Michiels; Aurélie Le Maître; Marc Buyse; Tomasz Burzykowski; Emilie Maillard; Jan Bogaerts; Jan B Vermorken; Wilfried Budach; Thomas F Pajak; Kian K Ang; Jean Bourhis; Jean-Pierre Pignon
Journal:  Lancet Oncol       Date:  2009-02-24       Impact factor: 41.316

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  10 in total

1.  The Importance of Verification CT-QA Scans in Patients Treated with IMPT for Head and Neck Cancers.

Authors:  Jaden D Evans; Riley H Harper; Molly Petersen; William S Harmsen; Aman Anand; Ashley Hunzeker; Noelle C Deiter; Heather Schultz; Krishan R Jethwa; Scott C Lester; David M Routman; Daniel J Ma; Yolanda I Garces; Michelle A Neben-Wittich; Nadia N Laack; Chris J Beltran; Samir H Patel; Lisa A McGee; Jean-Claude M Rwigema; Daniel W Mundy; Robert L Foote
Journal:  Int J Part Ther       Date:  2020-08-03

Review 2.  Proton Therapy for HPV-Associated Oropharyngeal Cancers of the Head and Neck: a De-Intensification Strategy.

Authors:  Nicolette Taku; Li Wang; Adam S Garden; David I Rosenthal; G Brandon Gunn; William H Morrison; C David Fuller; Jack Phan; Jay P Reddy; Amy C Moreno; Michael T Spiotto; Gregory Chronowski; Shalin J Shah; Lauren L Mayo; Neil D Gross; Renata Ferrarotto; X Ronald Zhu; Xiaodong Zhang; Steven J Frank
Journal:  Curr Treat Options Oncol       Date:  2021-06-04

3.  Predicted Secondary Malignancies following Proton versus Photon Radiation for Oropharyngeal Cancers.

Authors:  Varsha Jain; Peyton Irmen; Shannon O'Reilly; Jennifer H Vogel; Liyong Lin; Alexander Lin
Journal:  Int J Part Ther       Date:  2020-04-22

Review 4.  Assessing Novel Drugs and Radiation Technology in the Chemoradiation of Oropharyngeal Cancer.

Authors:  Agostino Cristaudo; Mitchell Hickman; Charles Fong; Paul Sanghera; Andrew Hartley
Journal:  Medicines (Basel)       Date:  2018-06-27

Review 5.  The Reality of Randomized Controlled Trials for Assessing the Benefit of Proton Therapy: Critically Examining the Intent-to-Treat Principle in the Presence of Insurance Denial.

Authors:  Mike Hernandez; J Jack Lee; Beow Y Yeap; Rong Ye; Robert L Foote; Paul Busse; Samir H Patel; Roi Dagan; James Snider; Nasiruddin Mohammed; Alexander Lin; Pierre Blanchard; Scott B Cantor; Menna Y Teferra; Kate Hutcheson; Pablo Yepes; Radhe Mohan; Zhongxing Liao; Thomas F DeLaney; Steven J Frank
Journal:  Adv Radiat Oncol       Date:  2020-12-02

6.  A Decision Support Tool to Optimize Selection of Head and Neck Cancer Patients for Proton Therapy.

Authors:  Makbule Tambas; Hans Paul van der Laan; Arjen van der Schaaf; Roel J H M Steenbakkers; Johannes Albertus Langendijk
Journal:  Cancers (Basel)       Date:  2022-01-28       Impact factor: 6.639

7.  Patient-Reported Outcomes after Intensity-Modulated Proton Therapy for Oropharynx Cancer.

Authors:  Houda Bahig; Brandon G Gunn; Adam S Garden; Rong Ye; Kate Hutcheson; David I Rosenthal; Jack Phan; Clifton D Fuller; William H Morrison; Jay Paul Reddy; Sweet Ping Ng; Neil D Gross; Erich M Sturgis; Renata Ferrarotto; Maura Gillison; Steven J Frank
Journal:  Int J Part Ther       Date:  2021-06-25

8.  Cost-Effectiveness Models of Proton Therapy for Head and Neck: Evaluating Quality and Methods to Date.

Authors:  Danmeng Huang; Steven J Frank; Vivek Verma; Nikhil G Thaker; Eric D Brooks; Matthew B Palmer; Ross F Harrison; Ashish A Deshmukh; Matthew S Ning
Journal:  Int J Part Ther       Date:  2021-06-25

9.  Proton Beam Therapy for Head and Neck Carcinoma of Unknown Primary: Toxicity and Quality of Life.

Authors:  Alexander D Sherry; Dario Pasalic; G Brandon Gunn; C David Fuller; Jack Phan; David I Rosenthal; William H Morrison; Erich M Sturgis; Neil D Gross; Maura L Gillison; Renata Ferrarotto; Adel K El-Naggar; Adam S Garden; Steven J Frank
Journal:  Int J Part Ther       Date:  2021-06-25

10.  Proton Therapy for Head and Neck Cancer: A 12-Year, Single-Institution Experience.

Authors:  G Brandon Gunn; Adam S Garden; Rong Ye; Noveen Ausat; Kristina R Dahlstrom; William H Morrison; C David Fuller; Jack Phan; Jay P Reddy; Shalin J Shah; Lauren L Mayo; Stephen G Chun; Gregory M Chronowski; Amy C Moreno; Jeffery N Myers; Ehab Y Hanna; Bita Esmaeli; Maura L Gillison; Renata Ferrarotto; Katherine A Hutcheson; Mark S Chambers; Lawrence E Ginsberg; Adel K El-Naggar; David I Rosenthal; Xiaorong Ronald Zhu; Steven J Frank
Journal:  Int J Part Ther       Date:  2021-06-25
  10 in total

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