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Nrg Oncology Rtog 1016 Phase Iii Trial Of NRG ONCOLOGY RTOG 1016 PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI). The trial will be led by NRG Oncology with the participation of the network of NCTN organizations: the Alliance for Clinical Trials in Oncology; ECOG-ACRIN Medical Research Foundation, Inc.; and SWOG. Study Team (6/3/14) Co-Principal Investigator/Radiation Oncology Radiation Oncology Co-Chair Andy Trotti, MD Paul Harari, MD Moffitt Cancer Center/University of South Florida University of Wisconsin Hospital 12902 Magnolia Drive 600 Highland Avenue Tampa, FL 33612 Madison, WI 53792 813-745-3547/FAX 813-745-7231 608-263-5009/FAX 608-262-6256 [email protected] [email protected] Co-Principal Investigator/Pathology & Translational Research Surgical Oncology Co-Chair Maura Gillison, MD, PhD Erich Sturgis, MD, MPH Ohio State University Medical Center MD Anderson Cancer Center 420 W. 12th Avenue, Room 690 1515 Holcombe Blvd Columbus, OH 43210 Houston, TX 77030 614-247-4589/FAX 614-688-4245 713-792-5432/FAX 713-794-4662 [email protected] [email protected] Medical Oncology Co-Chair Medical Physics Co-Chair David J. Adelstein, MD James Galvin, PhD Cleveland Clinic Taussig Cancer Institute Jefferson Medical College 9500 Euclid Avenue, Desk R35 111 S. 11th Street Cleveland, OH 44195 Philadelphia, PA 19107 216-444-9310/FAX 216-444-9464 215-955-8855/FAX 215-955-0412 [email protected] [email protected] Radiation Oncology Co-Chair Medical Physics and Radiobiology Co-Chair Avraham Eisbruch, MD Søren Bentzen, PhD University of Michigan Medical Center University of Maryland 1500 E. Medical Center Drive, Box 0010 655 W. Baltimore St., HH 109D Ann Arbor, MI 48109 Baltimore, MD 21201 734-936-9337/FAX 734-763-7370 410-706-8506/FAX 410-706-8548 [email protected] [email protected] Study Chairs continued on next page 1 RTOG 1016, Version Date: 2/23/16 NRG ONCOLOGY RTOG 1016 PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER Study Team (Continued) (2/23/16) Pathology Co-Chair Hearing Assessment Co-Chair Richard Jordan, DDS, PhD Christina L. Runge, PhD NRG Oncology Biospecimen Bank Medical College of Wisconsin University of California San Francisco 9200 W. Wisconsin Avenue 1657 Scott St., Rm 223 Milwaukee, WI 53226 San Francisco, CA 94115 414-805-5562/FAX 414-805-7936 415-476-7864/FAX 415-476-5271 [email protected] [email protected] Quality of Life Co-Chair ECOG-ACRIN Co-Chair/Medical Oncology Jolie Ringash, MD, MSc Barbara Burtness, MD The Princess Margaret Hospital Yale University School of Medicine 610 University Avenue 333 Cedar Street Toronto, Ontario, Canada M5G 2M9 New Haven, CT 06520 416-946-4662/FAX 416-946-2111 203-737-7636/FAX 203-785-4116 [email protected] [email protected] PRO-CTCAE Co-Chair ECOG-ACRIN Co-Chair/Surgical Oncology Ethan Basch, MD John A. Ridge, MD Univ. Of N. Carolina-Chapel Hill Fox Chase Cancer Center 170 Manning Dr., Physician’s Office Bldg. 333 Cottman Avenue Chapel Hill, NC 27599 Philadelphia, PA 19111 919-843-3055/FAX 919-966-6735 215-728-3517/FAX 215-214-4222 [email protected] [email protected] Cost Utility Co-Chair Senior Statistician André Konski, MD Qiang Zhang, PhD The Chester County Hospital NRG Oncology 701 E. Marshall Street 1818 Market Street, Suite 1720 West Chester, PA 19380 Philadelphia, PA 19103 610-431-5530/FAX 610-431-5144 215-574-3197/FAX 215-928-0153 [email protected] [email protected] Employment Status Co-Chair Victoria Blinder, MD, MSc Memorial Sloan-Kettering Cancer Center 307 E. 63rd Street, Second Floor New York, NY 10065 646-735-8078/FAX 646-735-0011 [email protected] 2 RTOG 1016, Version Date: 2/23/16 NRG ONCOLOGY RTOG 1016 PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER Protocol Agents (10/17/13) Agent Supply NSC # IND # Cisplatin Commercial N/A Exempt Cetuximab Commercial N/A Exempt Participating Sites (10/17/13) US Only Canada Only US and Canada Approved International Member Sites Document History Version/Update Date Broadcast Date Amendment 8 February 23, 2016 March 28, 2016 Closure July 31, 2014 July 31, 2014 Amendment 7 July 16, 2014 July 31, 2014 Amendment 6 June 3, 2014 July 31, 2014 Update March 26, 2014 March 26, 2014 Update December 10, 2013 December 10, 2013 Re-Opened to Accrual October 17, 2013 December 10, 2013 Amendment 5 October 17, 2013 December 10, 2013 Amendment 4 June 25, 2013 August 5, 2013 Closure June 25, 2013 August 2, 2013 Update December 4, 2012 December 4, 2012 Amendment 3 September 20, 2012 December 4, 2012 Amendment 2 June 28, 2012 July 17, 2012 Update January 9, 2012 January 9, 2012 Amendment 1 December 14, 2011 January 9, 2012 Update November 3, 2011 November 3, 2011 Update June 9, 2011 June 9, 2011 Activation June 9, 2011 June 9, 2011 NRG Oncology 1-800-227-5463, ext. 4189 This protocol was designed and developed by NRG Oncology. It is intended to be used only in conjunction with institution-specific IRB approval for study entry. No other use or reproduction is authorized by NRG Oncology nor does NRG Oncology assume any responsibility for unauthorized use of this protocol. 3 RTOG 1016, Version Date: 2/23/16 NRG ONCOLOGY RTOG 1016 PHASE III TRIAL OF RADIOTHERAPY PLUS CETUXIMAB VERSUS CHEMORADIOTHERAPY IN HPV-ASSOCIATED OROPHARYNX CANCER CANCER TRIALS SUPPORT UNIT (CTSU) CONTACT INFORMATION (2/23/16) To submit site For patient enrollments: Submit study data directly to the Lead registration documents: Cooperative Group unless otherwise specified in the protocol: CTSU Regulatory Office Please refer to Section 5.0 NRG Oncology 1818 Market Street, Suite of the protocol for 1818 Market Street, Suite 1720 1100 instructions on using the Philadelphia, PA 19103 Philadelphia, PA 19103 OPEN system. Phone – 1-866-651-CTSU Submit data electronically via the NRG Fax – 215-569-0206 Contact the CTSU Help Oncology/RTOG web site, www.rtog.org Email: Desk with any OPEN- [email protected] related questions at Do not submit study data or forms to cg.org (for submitting [email protected]. CTSU Data Operations. Do not copy the regulatory documents only) CTSU on data submissions. The most current version of the study protocol and all supporting documents must be downloaded from the protocol-specific Web page of the CTSU Member Web site located at https://www.ctsu.org. Access to the CTSU members’ web site is managed through the Cancer Therapy and Evaluation Program - Identity and Access Management (CTEP-IAM) registration system and requires user log on with CTEP-IAM username and password. For patient eligibility or treatment-related questions Contact the Study PI of the Lead Protocol Organization. For questions unrelated to patient eligibility, treatment, or data submission contact the CTSU Help Desk by phone or e-mail: CTSU General Information Line – 1-888-823-5923, or [email protected]. All calls and correspondence will be triaged to the appropriate CTSU representative. For detailed information on the regulatory and monitoring procedures for CTSU sites please review the CTSU Regulatory and Monitoring Procedures policy located on the CTSU members’ web site https://www.ctsu.org > education and resources tab > CTSU Operations Information >CTSU Regulatory and Monitoring Policy The CTSU web site is located at https://www.ctsu.org 4 RTOG 1016, Version Date: 2/23/16 Table of Contents (3/26/14) SCHEMA ...................................................................................................................................................... 7 ELIGIBILITY CHECKLIST – STEP 1 ............................................................................................................ 8 ELIGIBILITY CHECKLIST –STEP 2 ........................................................................................................... 12 1.0 INTRODUCTION ............................................................................................................................. 13 1.1 Background ................................................................................................................................. 13 1.2 RTOG 1016 Trial Design and Rationale ..................................................................................... 19 1.3 Rationale for Eligibility ................................................................................................................. 20 1.4 Rationale for Study Arms ............................................................................................................ 20 1.5 Toxicity, Patient-Reported Outcomes (PROs) and Quality of Life (QOL) ................................... 20 1.6 Outcomes and Cost Effectiveness .............................................................................................. 30 1.7 Epidemiological and Translational Research .............................................................................. 30 2.0 OBJECTIVES .................................................................................................................................. 36 2.1 Primary Objective ........................................................................................................................ 36 2.2 Secondary Objectives ................................................................................................................. 36 3.0
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