For Protocol Amendment 5 of: RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy For Favorable Risk Prostate Cancer

Transcription

1 Section For Protocol Amendment 5 of: RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy For Favorable Risk Prostate Cancer NCI/Local Protocol #: RTOG-0938/RTOG 0938 NCI Protocol Version Date: May 20, 2016 (Broadcast: June 27, 2016) Administrative Changes Document This amendment was added. History table Changes to the constraint were made as follows, because they were inadvertently not made during the previous amendment: Table titled 5 Fraction Arm Column 2, Line 4: (1cc) replaces (0.03cc) Column 2, Line 9: (1cc) replaces (0.03cc) Table titled 12 Fraction Arm Column 2, Line 4: (1cc) replaces (0.03cc) Column 2, Line 9: (1cc) replaces (0.03cc) Table footnote, first asterisk: (0.03cc) is added after max point dose Appendix V Appendix I: Informed Consent Submission logistics for the NRG Oncology Biospecimen Bank were updated per current NRG Oncology Biospecimen Bank process. No changes

2 For Protocol Amendment 4 of: RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy For Favorable Risk Prostate Cancer NCI/Local Protocol #: RTOG-0938/RTOG 0938 NCI Protocol Version Date: December 15, 2015 (Broadcast: December 28, 2015) Section Document History table Page 1, Title Page, Study Chairs list Change This amendment was added. The address for Himu Lukka was updated: Changed from: Himu.Lukka@jcc.hhsc.ca Changed to: Himu.Lukka@hhsc.ca Appendix I/Sample Consent No changes

3 For Protocol Amendment 3 of RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy For Favorable Risk Prostate Cancer, to update the protocol cover pages for NCTN terminology. NCI/Local Protocol #: RTOG-0938/RTOG 0938 NCI Protocol Version Date: December 22, 2014 (Broadcast Date: January 20, 2015) Section Cover/Schema Pages Appendix I/ Sample Consent Change Due to the transition to the National Clinical Trials Network (NCTN), Radiation Therapy Oncology Group, RTOG Headquarters, and RTOG were replaced with NRG Oncology. Contact information was updated for Dr. Pugh. This amendment was added to the Document History Table. No changes

4 For Protocol Administrative Update of RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer NCI/Local Protocol #: RTOG-0938/RTOG 0938 NCI Protocol Version Date: July 24, 2013 Update Broadcast Date: April 30, 2014 Section Change 6.11 As required by CTEP, references to the Adverse Event Reporting System (AdEERS) have been changed to CTEP Adverse Event Reporting System (CTEP-AERS) throughout this section Title page The section numbers were corrected; the subsequent sections were renumbered. Corresponding section reference correction at the end of Section 4.3. This update was added to the Document History table.

5 SUMMARY OF CHANGES Amendment 2: July 24, 2013 (Broadcast: August 9, 2013) RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer Study Chair: Himu Lukka, MD, ext.64702, Himu.Lukka@jcc.hhsc.ca RTOG 0938 has been amended as follows: The sample size for this trial was increased to account for patient non-compliance, specifically missing completed EPIC assessments at baseline and 1 year. The following sections of the protocol were revised accordingly: Schema page: The required sample size at the bottom of the page was revised. Section : The last sentence of this section was revised for the new sample size. Section : The accrual details were updated for the new sample size. Section 13.9: The gender and minorities projected distribution table was revised. Appendix I: Under How many people will take part in the study? The number of participants was revised from 174 to 240. Other changes to the protocol include: Title page: Document history table updated for the Amendment. Section 3.1: Instructions for contacting RTOG or the Principal Investigator with questions about eligibility were inserted at the beginning of the section. Section : In each table (5 Fraction Arm and 12 Fraction Arm), the maximum point dose for prostate, rectum, and bladder was revised from 1cc to 0.03cc to make the tables consistent with the text in Section The same revision was made in the note (denoted by asterisk*) at the bottom of the 5 Fraction Arm table. Sections and : Updated per RTOG current format for this section. Section and : Updated for clarity per current RTOG Biospecimen Resource procedure. Section : Last sentence inserted for clarity regarding completion of assessments.

6 SUMMARY OF CHANGES Update: November 8, 2012 (Broadcast: November 8, 2012) RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer Study Chair: Himu Lukka, MD, ext.64702, Himu.Lukka@jcc.hhsc.ca RTOG 0938 has been updated as follows: Title Page: Dr. Stephanie Shook s last name (Pugh) and address updated. Section : Typographical errors corrected.

7 SUMMARY OF CHANGES Amendment 1: October 22, 2012 (Broadcast: November 8, 2012) RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer Study Chair: Himu Lukka, MD, ext.64702, Himu.Lukka@jcc.hhsc.ca RTOG 0938 has been amended as follows: Title page: City and state added to Dr. Bruner s contact information; document history table updated for the Amendment. Section 3.1.1: Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization revised to Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days (1 year) of randomization. Corresponding changes made on the Schema page (Patient Population), and in the Eligibility Checklist (page 1, question 1). Section : Inserted to provide further detail regarding patient eligibility. Section 3.1.3: Gleason scores 2-6 within 180 days of randomization revised to Gleason scores 2-6 within 365 days (1 year) of randomization. Corresponding changes made in the Eligibility Checklist (page 1, question 3), and in Appendix II (Study Parameter Table). Section 3.2.1: The criterion was revised from carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed to All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer). Corresponding change made in the Eligibility Checklist (page 1, question 9). Section Updated per current RTOG regulatory requirements. Section 5.6.2: Deleted; the Health Canada forms are not required for this study. The subsequent section was renumbered. Section : Updated per current RTOG regulatory requirements. Section 5.7.1: Revised the second sentence in the last paragraph regarding web registration details. Section 6.0: The time frame for start of protocol treatment was revised from within 4 weeks after randomization to within 6 weeks after randomization. Section 6.4.1: Sentence, Prone position is discouraged but allowed if tracking is used was inserted. Section : Revised for clarity. Section 6.9.3: The second sentence, The maximum point dose to normal critical structures outside the PTV including the unspecified tissue should not exceed the prescription dose, was deleted. Section 12.1: Regarding submission of the Follow-up Form (F1): 1, 2, and 5 years after the completion of radiation therapy was revised to Every 3 months for the first 2 years, every 6 months for years 3, 4, and 5, then annually after the completion of radiation therapy for consistency with post-treatment details RTOG 0938 Amendment 1: Summary of Changes Page 1 of 2

8 in Section 11.4; corresponding change ( every 6 months for years 3, 4, and 5, then annually ) made in Appendix II (Study Parameter Table). Section 13.7: First paragraph regarding interim reports was added. Section 13.8: Added paragraph regarding the reporting of initial treatment results. The section previously numbered 13.8, Gender and Minorities is now Section Appendix I (Sample Consent): In the Quality of Life Study section, added a choice for electronic completion of the quality of life questionnaires using the VisionTree software. RTOG 0938 Amendment 1: Summary of Changes Page 2 of 2

9 SUMMARY OF CHANGES Update: November 17, 2011 (Broadcast: November 17, 2011) RTOG 0938, A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer Study Chair: Himu Lukka, MD, ext.64702, Himu.Lukka@jcc.hhsc.ca RTOG 0938 has been updated as follows: Section 12.2: Under Summary of Dosimetry Digital Data Submission The data submission information included in the third and fourth bulleted items under Preliminary Dosimetry Information was updated. IGRT submission details were added at the end of the list, immediately above Section The street address for the RTOG Biospecimen Resource was updated in Section and throughout Appendix V.