0518 Broadcast DATE: April 24, 2008 SUBJECT: RTOG 0518, Amended Amended RTOG 0518, "A Phase III Randomized Trial to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer," Amendment 4: Study arm 2 was changed from placebo and standard treatment to standard treatment alone. In addition, frequency of treatment was reduced to decrease risk from potential zoledronic acid toxicities. Please see the complete Summary of Changes at http://www.rtog.org/members/protocols/0518/summary_changes.html. You may download a copy of the Protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0518/0518.pdf. NCI policy requires that the "Version Date" on the Protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org. Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 18, 2007 SUBJECT: RTOG Holiday Drug Shipment Hours The deadline to order drug for the holidays is approaching fast. Please be aware of your institution's supply of pharmaceutical supplied drugs during the holiday shipment hiatus and reorder now or plan accordingly. BMS [(0324), (0234) & 0522] the distributor of Cetuximab/Erbitux reminds us: The holiday season is quickly approaching. We remind you that BMS drug distribution center will be closed for Cetuximab shipments as follows: Warehouse Closure Date Last Shipment Date Monday, December 24th through Wednesday, January 2nd, 2008 Wednesday, December 19th BIOLOGICS [(9813), 0525 & 0521] and IV SOLUTIONS [0227, 0320, 0424, 0517 & 0518] the distributors of TEMOZOLOMIDE, TAXOTERE & ZOMETA on behalf of the supporting pharmaceutical companies for RTOG studies remind us: The holiday season is quickly approaching. The BIOLOGICS & IV SOLUTIONS drug distribution centers will be closed for all drug shipments as follows: Dates of Closure Comments Monday 12/24/07 Shipment sent on Friday 12/21/07will be delivered on Monday 12/24/07. Tuesday 12/25/07 Monday 12/31/07 Shipments sent on Friday 12/28/07 will be delivered on Monday 12/31/07. Tuesday 01/01/08 DATE: August 30, 2007 SUBJECT: RTOG 0518, Amended Amended RTOG 0518, "A Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer," Amendment 3: Changes were made to the Eligibility Checklist; Sections 3, 11, and 12; and Appendix I (the sample consent) . Please see the complete summary of changes at http://www.rtog.org/members/protocols/0518/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0518/0518.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org Web registration is available 24/7. Information and instructions available at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 29, 2007 SUBJECT: Form Revision Notice - RTOG 0518 FORM REVISION RTOG 0518 Phase III Prevent Osteo The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0518/0518i1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form ;   I1b     8-29-07   Changes Made: Question #6 and Question #8 updated to correspond to recent eligibility/amendment updates. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after September 10, 2007 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. D. Grant, RN RTOG Data Management Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 5, 2007 SUBJECT: RTOG 0518 & 0517 PROTOCOL NOTICE: NOVARTIS SAFETY REPORT FOR ZOMETA RTOG has received safety report(s) from Novartis for ZOMETA The Following RTOG studies involve ZOMETA: RTOG 0518 "A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer" RTOG 0517 "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast and Prostate Cancer" The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do not require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - PHHO2007DE09444 - CIOMS form.pdf Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org. Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: April 3, 2007 SUBJECT: RTOG 0518, Amended Amended RTOG 0518, "A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer", Amendment 2: At the recommendation of Novartis, the maker of Zometa®, a paragraph was added to the sample consent concerning risks of zoledronic acid; please see the complete summary of changes at http://www.rtog.org/members/protocols/0518/summary_changes.html Sites can download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0518/0518.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments.If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: March 16, 2007 SUBJECT: Protocol RTOG 0518 Amendment#1 - Health Canada Approval PLEASE NOTE: This is a re-broadcast for several sites did not receive the initial broadcast sent on 2/15/07. Thanks. RTOG 0518: “A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer” (Amendment#1) Regulatory Note: Prior to clinical trial commencement, there are three TPD forms that need to be completed for each site. They are as follows: Clinical Trial Site Information Form Qualified Investigator Undertaking Form Research Ethics Board Attestation Form for the current version of the protocol Each form is attached with the RTOG information included. Please complete each form and forward the packet to the RTOG Regulatory Compliance Department (fax 215-574-0300). Also, please forward your REB approval for this protocol. Should there be any REB refusals, the TPD must be notified. Once all forms have been received and reviewed at RTOG Headquarters, the Clinical Trial Site Information Form will be faxed to TPD for study commencement. The No Objection Letter is also included for your convenience. - 0518 NOL_Amendment1.pdf - 0518 Research ethics board attestation.doc - 0518 Qualified investigator undertaking.doc - 0518 Clinical trial site form.doc Please visit the Canadian Information Section of the RTOG Website for access to these and other study related templates of required Health Canada forms for all studies involving a Health Canada CTA at the following link: http://www.rtog.org/members/CanadaInfo/main.html (Please note: 48 hours may be required for forms attached to recent broadcasts to be available on the site) If questions arise regarding this broadcast, please contact Erin Cunningham at ecunningham@phila.acr.org or 215-717-0831 or Marie D’Amico at mdamico@phila.acr.org or 215-574-3185. Please notify your affiliates who are not on this e-mail. Thank you. DATE: February 16, 2007 SUBJECT: RTOG 0518 & 0517 PROTOCOL NOTICE: NOVARTIS SAFETY REPORT FOR ZOMETA RTOG has received safety report(s) from Novartis for ZOMETA The Following RTOG studies involve ZOMETA: RTOG 0518 “A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteopor>osis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer” RTOG 0517 “Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast and Prostate Cancer” The safety report(s) are sent automatically to the sites that have patients enrolled in the study. Although the safety report(s) included here do no require revisions to the protocol at this time, a copy must be sent to your IRB. A copy must also be retained in the protocol study file. - 090207_ZOL446E_ZOL446G_ZOL446D_Atrial fibrillation_Final.doc Please note a CIOMS Form was not provided by Novartis for this report. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189, which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 23, 2007 SUBJECT: RTOG 0518: Pharmacy Manual and Administrative Guidelines For sites participating in RTOG 0518,, "A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer" A document, "Pharmacy Manual and Administrative Guidelines", is attached for the person at each site who receives and prepares the study agent. Note: This person should not unblind the treatment to the administrator of the study agent. This document also will be available on the RTOG web site, next to the protocol, in the near future. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html - Pharm Manual/Admin Guidelines DATE: January 18, 2007 SUBJECT: Form Revision Notice - RTOG 0518 FORM REVISION RTOG 0518 Phase III Osteo Prevention The following form for this study has been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0518/0518t1.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date T1 Radiotherapy Form    T1a     1-18-07   Changes Made: Added additional option under type of modality used. Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after January 30, 2007 will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Denise Manfredi RTOG RT Quality Assurance DATE: January 11, 2007 SUBJECT: RTOG 0518, Amended and Updated Amended and Updated RTOG 0518, “A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer” Amendment 1: Changes to Sections 3, 4, 7, 11, and Appendix I; please see the complete summary of changes at http://www.rtog.org/members/protocols/0518/summary_changes.html Update: Clarification regarding the placebo “kit” and clarification that the person receiving and preparing the study agent should not unblind the treatment to the administrator of the study agent; please see the complete summary of changes at http://www.rtog.org/members/protocols/0518/0518.pdf NCI policy requires that the "Version Date" on the protocol title page reflect the date the amendment was submitted by RTOG to NCI; for clarity, the broadcast date is provided in parentheses. The "Update Date" indicates that editorial/administrative changes were made to the protocol after NCI approved the amendment. NCI requires that these changes be documented on the protocol title page as an update, not as an amendment. IRB review of an update is not required; however, these changes must be reported to site IRBs. Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days. Expedited review is allowed; however, site IRB requirements take precedence. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments.If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 04, 2007 SUBJECT: RTOG 0517 & 0518 Protocol Notice: Novartis SAFETY REPORT FOR ZOMETA RTOG has received safety report(s) from the Novartis for Zometa The Following RTOG study(s) involve Zometa: RTOG 0518 “A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer” RTOG 0517 “Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast and Prostate Cancer” Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file. - 061212bzol446MigrainePHHO2006ES20182_IN_final.doc - PHHO2006ES20182 15Dec2006.pdf Please notify your affiliates that are not on e-mail. The safety report(s) do not require revisions to the above protocol at this time. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: January 04, 2007 SUBJECT: RTOG 0518: Important information regarding placebo For Investigators participating in RTOG 0518, “A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer” Important information regarding placebo: For patients randomized to placebo on RTOG 0518, sites will receive an infusion bag, label, and tubing “kit” identical to that provided for patients randomized to Zometa®. Vials of placebo (i.e., sterile water or saline) for addition to the infusion bag are not supplied. Instead, dispensing instructions for the site pharmacist will be included with the placebo “kit” to prepare the placebo on site to look like Zometa®. I.V. Solutions, Inc. distributes both the Zometa® with label and tubing and its matching placebo “kit”, and both Zometa® and the placebo “kit” are free of charge to patients on study. The protocol will be updated in the future to provide this information. Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments.If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 20, 2006 SUBJECT: RTOG 0517 & 0518 Protocol Notice: Novartis SAFETY REPORT FOR ZOMETA The safety report(s) do not require revisions to the above protocol at this time. RTOG has received safety report(s) from the Novartis for Zometa The Following RTOG study(s) involve Zometa: RTOG 0518 "A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer" RTOG 0517 "Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases from Lung, Breast and Prostate Cancer" - 061122aCZOL446EGlucose elevatedtachyarrthymiaPHHO2006KR19331_IN_final.doc - IN-Glucose Elevation-CIOMS.pdf - IN_Aclasta_ZOL446(zoledronic acid)_Deafness_.pdf - PHHO2006GB19877_CIOMS form-Deafness.pdf - 061212azol446MigrainePHHO2006ES20182_IN_final.doc - IN-Zometa-Migraine.pdf Please send the report(s) to your institutional IRB. A copy also should be retained in your protocol file. Please notify your affiliates that are not on e-mail. Note: You will need "Adobe Acrobat Reader" to read the attached PDF document; this program can be downloaded free of charge at http://www.adobe.com/products/acrobat/readstep.html Please notify your affiliates that are not on e-mail. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact Michelle Buado at mbuado@phila.acr.org Please do not contact Michelle Buado for any other reason or reply directly to this broadcast but contact the appropriate department at RTOG HQ to share a comment or ask a question. A telephone listing by department is available on the website at www.rtog.org by selecting the member info tab and clicking Headquarters Information and Telephone Listings. You may also use 1-800-227-5463 ext. 4189 which provides a menu to reach the different departments. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 15, 2006 SUBJECT: Form Revision Notice - RTOG 0518 FORMS REVISION RTOG 0518 Phase III Osteo Prevention The following forms for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/members/forms/0518/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date I1 Initial Evaluation Form I1a   12/15/06 TF Treatment Summary Form TFa   12/15/06 DA DXA Scan Data Form DAb   12/15/06 F1 Follow-Up Form F1a   12/15/06   Changes Made: The AE form (adverse event form) has been incorporated into both of these forms. Please note that the AE form will no longer be listed in the data collection section of the protocol (section 12--amendment forthcoming); will no longer be available as a separate form (in the forms packet or forms listing) and will no longer be listed on the study specific calendar.   TF: The AE (adverse event form) was combined with this form and now appears as Question 14 rather than a separate form.   F1: The AE (adverse event form) was combined with this form and now appears as Question 12 rather than a separate form.   DA: Question 3A was added to ask a reason why scan was not performed at the specified timepoint. Discard obsolete versions and commence use of the revised editions immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka Welsh, RN, MSN, CCRP RTOG Research Associate Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 09, 2006 SUBJECT: IMPORTANT RTOG DRUG ACCOUNTABILITY INFORMATION RTOG will now require study-specific drug accountability recording forms (DARFs) for pharmaceutical-supplied studies. Study specific DARFs will be posted on the RTOG web site with the study forms, as well as in the initial broadcast for each protocol requiring drug review. Starting January 2007 these forms will be reviewed as part of the RTOG audit, but will not be part of the final CTMB audit score. No deficiencies will be cited for any documentation inaccuracies prior to January 2007. A count of these pharmaceutical-supplied drugs will be required at the audit, hence a pharmacy visit will need to be scheduled as part of the audit. The next studies transitioning to this new system will be those utilizing Zometa- RTOG 0517 and 0518 Patients on studies meant to receive drug free of charge must not receive commercial drug and be charged for it. Please watch for other pharmaceutical supplied study related broadcasts in the near future- thank you! - RTOG 0517 Investigational Agent Accountability Record [doc] - RTOG 0518 Investigational Agent Accountability Record [doc] DATE: July 26, 2006 SUBJECT: RRTOG 0518, Site reimbursement Site reimbursement for: RTOG 0518, "A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer" Additional reimbursement in the amount of $2000 per case is available for this study for patients' DXA scans, spine films, and supplements. (Zometa®, its matching placebo, and administration supplies [tubing, etc.] are provided to patients on study free of charge.) Sites can access the details on the RTOG web site, next to the protocol at http://www.rtog.org/members/protocols/0518/0518_supplemental_funding.doc Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: July 11, 2006 SUBJECT: Forms Revision Notice - RTOG 0518 RTOG 0518 Phase III Osteo Prevention The following forms for this study have been revised. Download the new versions from the RTOG web site at http://www.rtog.org/members/forms/0518/main.html The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code Date PQ Fact G PQa 7-11-06 HP Health Utility Measure (EQ-5D) HPa 7-11-06 Changes Made: The coversheets on both quality of life tools (PQ and HP) were amended to add a question about the time point being assessed. A sentence was added to the instructions asking that a patient label be affixed to each page of the tool after completion by the patient. The tools were also restyled so that they more closely resemble the original product. Discard obsolete versions and commence use of the revised editions immediately. Please notify your joint center institutions and affiliates who are not on e-mail. Elaine Motyka-Welsh, RN, MSN, CCRP RTOG Research Associate Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: June 29, 2006 SUBJECT: Form Revision Notice - RTOG 0518 The following form for this study have been revised. Download the new version from the RTOG web site at http://www.rtog.org/pdf_forms.html?members/forms=0518/0518da.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date DA DXA Scan Data Form DAa   6-29-06   Changes Made: The layout and schema have been revised. Question 8: The T Score reporting format has been changed. There are separate columns to collect positive or negative values. Discard obsolete versions and commence use of the revised editions immediately. Any obsolete versions received will be returned to the site for transcription. Please notify your joint center institutions and affiliates who are not on e-mail. Mary Gramkowski, RN, BA, CCRP RTOG Data Management DATE: March 28, 2006 SUBJECT: RTOG 0518, Activated Activated RTOG 0518, "A Phase III, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer" You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0518/0518.pdf Forms for this study are available on the RTOG web site at http://www.rtog.org/members/forms/0518/main.html A Study Agent Shipment Form for this study is available on the RTOG web site next to the protocol. Online (versus Dial-in) registration is mandatory for this study. See the link below for web registration information and instructions. NCI policy requires that the "Version Date" on the protocol title page reflect the date the protocol was submitted by RTOG to NCI; therefore, the version date and activation date are not the same. The "Update Date" (the same as the activation date) indicates that minor administrative changes were made to the protocol after NCI approval; these changes are detailed in a summary of changes, which can be accessed at http://www.rtog.org/members/protocols/0518/summary_changes.html Please notify your affiliates that are not on e-mail. To share a comment or ask a question, access the Headquarters Information and Telephone Listing on the RTOG web site, www.rtog.org, under "Member Info", or call 1-800-227-5463, ext. 4189, which provides a menu to reach the Headquarters departments. If you would like to be added/removed from the RTOG broadcast list or wish to update your e-mail address, contact David Corrie at dcorrie@phila.acr.org. Web registration is available 24/7. Information and instructions available at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html