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Protocol Template with Guidelines GYNECOLOGIC ONCOLOGY GROUP/ AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK GOG-0233/ACRIN 6671 UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING PRIOR TO PRIMARY CHEMORADIATION THERAPY TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA ≥4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE) (11/16/09) (11/16/09) Percapita Points: 15 Points Membership Points: 3 Points ACRIN Study Chair ACRIN Statistician (11/12/08) Mostafa Atri, M.D., Dip., Epid Zheng Zhang, Ph.D. NCSB 1C569 Toronto General Hospital Center for Statistical Sciences Department of Medical Imaging Brown University, Box G-S121 University Health Network 121 South Main Street, Box G-S121-7 585 University Avenue Providence, RI 02912 Toronto, ON Canada M5G 2N2 Tel: (401) 863-2578 Tel: (416) 340-4800 x3253 Fax: (401) 863-9182 Fax: (416) 480-5855 E-mail: [email protected] E-mail: [email protected] ACRIN Co-Chair ACRIN Pathologist Farrokh Dehdashti, M.D. Shahla Masood, M.D. Division of Nuclear Medicine University of Florida Mallinckrodt Institute of Radiology Department of Pathology 510 S. Kingshighway Blvd. 655 West 8th Street St. Louis, MO 63110 Jacksonville, FL 32209 Tel: 314-362-1474 Tel: (904) 244-3487 Fax: (314) 362-5428 Fax: (716) 845-8393 E-mail: [email protected] E-mail: [email protected] GOG Study Chair (11/12/08)(06/27/11) GOG Co-Chair Michael Gold, M.D. Wui-Jin Koh, M.D. Vanderbilt University Medical Center Fred Hutchinson Cancer Research Center Department of Obstetrics & Gynecology Puget Sound Oncology, Consortium, E-613 1161 21st Avenue South, B-1100 MCN 1100 Fairview Ave. N., P.O. Box 19024 Nashville TN 37232 22 S. Greene Street Tel: (615) 322-0093 Seattle, WA 98109 Fax: (615) 343-8403 Tel: (206) 598-4115 E-mail: [email protected] Fax: (206) 667-4695 E-mail: [email protected] CONFIDENTIAL GOG Co-Chair (11/16/09) GOG Statistician (06/09/08) Matthew A. Powell, M.D. Shamshad Ali, M.S. Dept. of OB/GYN, Division Gynecologic Oncology GOG Statistical & Data Center Washington University School of Medicine Roswell Park Cancer Inst. 4911 Barnes Jewish Hospital Plaza Elm & Carlton Streets St. Louis, MO 63110 Buffalo, NY 14263-0001 Tel: 314-362-1764 Tel: (716) 845-5702 Fax: 314-362-2893 Fax : (716) 845 8393 Email: [email protected] E-mail: [email protected] GOG Pathologist William H. Rodgers Ph.D., M.D. Chairman, Department of Pathology Lenox Hill Hospital 100 E 77th St. NY, NY 10021 Tel: (212) 434-2330 Fax: (212)434-2497 Email: [email protected] Coordinating Center GOG Statistical and Data Center GOG Administrative Office Roswell Park Cancer Institute Four Penn Center Elm & Carlton Streets 1600 JFK Blvd., Suite 1020 Buffalo, NY 14263-0001 Philadelphia, PA 19103 Tel: (716) 845-5702 Tel : (215) 854-0770 Fax: (716) 845-8393 Fax : (215) 854-0716 E-mail:www.gogstats.org E-mail : www.gog.org Version Date: June 25, 2012 Includes Amendments 1 – 11 Activation Date: September 24, 2007 (06/09/08)(09/09/08)(11/12/08)(06/01/09)(11/16/09)(06/27/11)(XX/XX/12) STUDY PARTICIPANTS: ALL GYNECOLOGIC ONCOLOGY GROUP MEMBERS AND AFFILIATE GYNECOLOGIC SURGEONS WHO HAVE MET THE QUALIFICATION REQUIREMENTS FROM ACRIN. (06/09/08) CONFIDENTIAL This protocol was designed and developed by the American College of Radiology Imaging Network (ACRIN) and Gynecologic Oncology Group (GOG). 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 ACRIN and GOG, nor does ACRIN and GOG assume any responsibility for unauthorized use of this protocol. PARTIAL PROTOCOL—CONTACT ACRIN PROTOCOL DEVELOPMENT AND REGULATORY COMPLIANCE FOR A COMPLETE PROTOCOL GOG-0233/ACRIN 6671 2 NCI Version Date: June 25, 2012 Activation Date: September 24, 2007 CONFIDENTIAL Table of Contents (06/09/08)(09/09/08)(11/12/08)(06/01/09)(11/16/09)(06/27/11)(XX/XX/12) Schema: Cervical Cancer Schema: Endometrial Cancer 1.0 Abstract ..................................................................................................................................9 2.0 Background and Significance ................................................................................................10 3.0 Specific Aims/Objectives.......................................................................................................14 4.0 Study Overview .....................................................................................................................15 5.0 Participant Selection ..............................................................................................................16 6.0 Site Selection .........................................................................................................................20 7.0 Online Registration System ...................................................................................................21 8.0 Surgical Treatment & PET/CT Scan Evaluation ...................................................................21 9.0 Study Procedures: Distinct for Cervical or Endometrial Cancer ...........................................27 10.0 Data Collection and Management ..........................................................................................35 11.0 Data Collection Forms: Cervical or Endometrial Cancer ......................................................38 12.0 Image Procedures ...................................................................................................................40 13.0 Drug Information ...................................................................................................................47 14.0 Clinical Staging and Lymphatic Evaluation ..........................................................................48 15.0 Pathology Information ...........................................................................................................49 16.0 Adverse Events Reporting .....................................................................................................50 17.0 Ethical Considerations ..........................................................................................................59 18.0 Conflict of Interest .................................................................................................................60 19.0 Publication Policy ..................................................................................................................60 20.0 Institutional Audits.................................................................................................................60 21.0 Statistical Considerations REMOVED FROM WEB VERSION ......................................62 References ..........................................................................................................................................68 GOG-0233/ACRIN 6671 3 NCI Version Date: June 25, 2012 Activation Date: September 24, 2007 CONFIDENTIAL Appendix I: FIGO Guidelines: Cervix Uteri ...............................................................................73 Appendix II: FIGO Guidelines: Corpus Uteri ..............................................................................75 Appendix III: Sample Informed Consent Forms: Cervical Cancer .......................................................................................................76 Endometrial Cancer ................................................................................................86 Appendix IV: Participating Institutions .........................................................................................96 Appendix V: Extraperitoneal Lymphadenectomy ........................................................................97 Appendix VI: Laparoscopic Pelvic and Abdominal Lymphadenectomy ......................................99 Appendix VII: Transperitoneal Lymphadenectomy........................................................................101 Appendix VIII: Guidelines for Laparoscopic Surgery......................................................................103 Appendix IX: Credentialing Procedures for PET/CT Imaging for this Study ...............................105 Appendix X: PET/CT Imaging Quality Control Standards ..........................................................106 Appendix XI: Database Archiving ................................................................................................108 Appendix XII: Responsibilities and Roles for Reporting of Adverse Events .................................110 GOG-0233/ACRIN 6671 4 NCI Version Date: June 25, 2012 Activation Date: September 24, 2007 CONFIDENTIAL GYNECOLOGIC ONCOLOGY GROUP/ AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK GOG-0233/ACRIN 6671 UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING PRIOR TO PRIMARY CHEMORADIATION THERAPY TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA ≥4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE) (11/16/09) SCHEMA: CERVICAL
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