0617 Broadcast DATE: May 21, 2008 SUBJECT: RTOG 0617, Specimen Shipments Attention Investigators for RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer": In Section 10.5.4.2.2, letter f: Buffy coat cryovials must be stored at -80 °C (NOT -4°C) until packed and must be shipped on dry ice (NOT ambient). Specimens must be shipped to the RTOG Biospecimen Resource as follows: US Postal mailing address (all non-courier packages) RTOG Biospecimen Resource UCSF, Campus Box 1800 (1657 Scott St, room 223) San Francisco, CA 94143-1800 FedEx/Courier address (all courier packages & frozen samples) RTOG Biospecimen Resource UCSF 1657 Scott Street, Room 223 San Francisco, CA 94115 Contact # 415.476.7864 Tel: 415-476-RTOG (7864) Fax: 415-476-5271 Email: RTOG@ucsf.edu The protocol will be updated in the near future. DATE: March 18, 2008 SUBJECT: Form Revision Notice - RTOG 0617 FORM REVISION RTOG 0617 Phase III NSCLC 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=0617/0617i1.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    I1c     3-17-08   Change Made: Question #9 expanded code table (returned to original version to include five choices) regarding histological type. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after April 1, 2008 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 Research Associate, Lung Team 215-574-3159 Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: February 13, 2008 SUBJECT: Web-Based Electronic Data Submission WEB-BASED ELECTRONIC DATA SUBMISSION Web-Based Electronic Data Submission is now available for the following RTOG forms: 0522 T1 Radiotherapy Form 0529 T1 Radiotherapy Form 0534 T1 Radiotherapy Form 0615 T1 Radiotherapy Form 0617 T1 Radiotherapy Form Per previous Broadcasts, web-based data submission became MANDATORY as of May 14, 2007 for all forms available for web-entry for all cases enrolled through RTOG. A complete listing of forms available for web data submission is available at http://www.rtog.org/members/webreg.html For technical support with web data submission, please email websupport@phila.acr.org Web registration is available 24/7. Information and instructions available at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: December 11, 2007 SUBJECT: Form Revision Notice - RTOG 0617 FORM REVISION RTOG 0617 Phase III NSCLC 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=0617/0617i1.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    Ilb     12-11-07   Changes Made: Question #6 expanded regarding histology and procedure for biopsy. Question #14 added to form requesting additional patient information. Discard obsolete versions and commence use of the revised edition immediately. Obsolete versions received after January 1, 2008 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 Research Associate Phone: 215-574-3159 Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 27, 2007 SUBJECT: RTOG 0617, Activated Activated RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer", is open to patient accrual, effective immediately. You may download a copy of the protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0617/0617.pdf Forms for this study also are available on the RTOG website at http://www.rtog.org/members/forms/0617/main.html Regulatory Notes: NCI policy requires that the "Version Date" of the protocol reflect the date that the protocol was submitted by RTOG to NCI; therefore, the version date and the activation date on the protocol title page 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 that can be accessed at http://www.rtog.org/members/protocols/0617/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 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://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: November 14, 2007 SUBJECT: Specific Technology Requirements for RTOG 0617 Ph.III High Dose 3DCRT/IMRT in NSCLC The NCI has established guidelines which must be met for thoracic IMRT. Since these guidelines are new, this protocol is the first cooperative group study to establish a credentialing process to meet these guidelines. The NCI Thoracic IMRT guidelines may be found at the RTOG website http://www.rtog.org RTOG Protocol #617 allows both 3DCRT and IMRT, and you must complete the Part I (General Information - 3DCRT and IMRT) questionnaire. If you intend to place patients on this protocol using only 3DCRT, you can skip the IMRT questions. If you intend to enter patients using either IMRT alone or using 3DCRT for some patients and IMRT for others, you should complete all questions in this questionnaire. (See attached) For more detailed credentialing information link to the Radiological Physics Center (RPC) website http://rpc.mdanderson.org/rpc Please be aware of the fact that you are only being asked to fill in information about the 0617 protocol at this time. We would like to capture additional information about other protocols you are involved with that require credentialing. However, we do not want to delay the process of obtaining the 0617 data. Please complete all information for 0617 as described above and return the form to the RTOG as quickly as possible. If you can also provide information pertaining to previous protocols, we welcome you to extend the information on the form and send it forward at a later date. For questions regarding the Facility Questionnaires contact: James M. Galvin, D.Sc. RTOG Group Physicist Phone: (215) 955-8855 Email: james.galvin@jeffersonhospital.org Upon successfully completion of all relevant requirements, notification will be given to the institution from the RTOG RT Quality Assurance Department that the institution is eligible to enter patients onto this study. RTOG will activate this study (open it for patient enrollment) on Tuesday, November 27, 2007. RTOG will broadcast on that date to notify institutions that the study is open to accrual. Important: RTOG strongly encourages investigators to complete the pre-registration for IMRT and 3D-CRT credentialing and to forward the protocol and forms to their site IRBs for review prior to November 27th. - Instructions for completing questionnaires 0617 110207.pdf - Part I 110207.pdf - Part II 110207.pdf - Part III 110207.pdf - Procedure for Dry Run Credentialing 110207.pdf DATE: November 5, 2007 SUBJECT: Form Revision Notice - RTOG 0617 FORM REVISION RTOG 0617 Phase III NSCLC 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/0617/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    I1b     11-5-07 F1 Follow-up Form    Fla     11-5-07 TF Treatment Summary Form    TFa     11-5-07   Changes Made: Question #6 on the I1 and question #9 on the F1 was expanded regarding results of pulmonary function tests. Element numbers were added to the TF form for description of AE. Please Note: Per previous Broadcasts this study is NOT YET OPEN TO ACCRUAL. Discard obsolete versions and commence use of the revised editions immediately. Obsolete versions received after study activation 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 Research Associate, Lung Team 215-574-3159 Web registration is available 24/7. Information and instructions are at https://silver1.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: October 5, 2007 SUBJECT: RTOG 0617: Activation Date Changed Change of Activation Date RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer" was approved by the NCI on August 20, 2007. RTOG provided a copy of the NCI approved protocol on the RTOG web site on August 21st to give sites time to complete the pre-registration requirements for IMRT and 3D-CRT credentialing and to forward the protocol and forms to their site IRBs for review before activation of the study. RTOG has not yet received IRB approvals from sites, and no sites have completed credentialing. Therefore, RTOG has postponed the date of activation of RTOG 0617. RTOG will activate this study (open it for patient enrollment) on Tuesday, November 27, 2007. RTOG will broadcast on that date to notify institutions that the study is open to accrual. Important: RTOG strongly encourages investigators to complete the pre-registration for IMRT and 3D-CRT credentialing and to forward the protocol and forms to their site IRBs for review prior to November 27th. Institutions can access the NCI approved protocol, protocol summary, and forms on the RTOG web site, http://www.rtog.org Please note that the study is NOT YET OPEN TO ACCRUAL. Please notify your affiliates who are not on e-mail. DATE: September 28, 2007 SUBJECT: RTOG 0617, Pre-Activation Reminder Pre-Activation Reminder: RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer" will be activated (opened for patient enrollment) on October 19, 2007. RTOG provided a copy of the NCI approved protocol on the RTOG web site on August 21st to give sites time to complete the pre-registration requirements for the study (see Section 5.1 of the protocol) and to forward the protocol and forms to their site IRBs for review before activation of the study. RTOG strongly encourages investigators to complete the pre-registration requirements for IMRT and 3D-CRT credentialing and site IRB review prior to the study activation date. The NCI approved protocol can be accessed at http://www.rtog.org/members/protocols/0617/0617.pdf Please notify your affiliates who are not on e-mail. DATE: September 18, 2007 SUBJECT: Forms for RTOG 0617 Now Available on RTOG Web Site Per the previous Pre-Activation Broadcast for RTOG 0617 on August 21, 2007 the forms for this study are now available on the RTOG web site. Please see below. RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer" was approved by the NCI on August 20, 2007. RTOG will activate this study (open it for patient enrollment) on October 19, 2007. RTOG will broadcast on that date to notify institutions that the study is open to accrual. Important: RTOG strongly encourages investigators to complete the pre-registration requirements for the study (see Section 5.1 of the protocol) and to forward the protocol and forms to their site IRBs for review prior to the activation date. This is to notify sites that all forms for this study are now available on the RTOG web site at http://www.rtog.org/members/forms/0617/main.html Please note that the study is NOT YET OPEN TO ACCRUAL. Please notify your affiliates who are not on e-mail. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 12, 2007 SUBJECT: RTOG 0617, Pre-Activation Reminder Concerning Credentialing Reminder Re: Pre-Activation Requirements for IMRT and 3D-CRT Credentialing RTOG 0617, "A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer" will be activated (opened for patient enrollment) on October 19, 2007. RTOG strongly encourages investigators to complete the pre-registration requirements for IMRT and 3D-CRT credentialing (see Section 5.1 of the protocol) prior to activation of the study. Institutions can download a copy of the NCI approved protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0617/0617.pdf Please notify your affiliates who are not on e-mail. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: September 5, 2007 SUBJECT: Form Revision Notice - RTOG 0617 QOL Forms FORM REVISION RTOG 0617 Phase III NSCLC 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=0522/0522tf.pdf The edition code for case report forms is found in the lower right corner of the form. Form Type New Version Code/Date HP Health Utility Measurement (EQ-5D) ;   HP     09/05/07 FA Functional Assessment ;   FA     09/05/07   Changes Made: The word “patient” has been removed from Question #3 on both forms. The wording has been changed for selection #3 for this question also. For Question #7 the wording has been changed on both forms. These changes have been made to make these forms CDE compliant. Please note that the study is NOT YET OPEN TO ACCRUAL. RTOG will activate this study (open it for patient enrollment) on October 19, 2007. RTOG will broadcast on that date to notify institutions that the study is open to accrual. Please notify your affiliates who are not on e-mail. Web registration is available 24/7. Information and instructions are at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 30, 2007 SUBJECT: RTOG 0617 - QOL Forms Now Available Per the previous Pre-Activation Broadcast for RTOG 0617 on August 21, 2007 the QOL Forms for this study are now available on the RTOG web site. Please see below. RTOG 0617, “A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer” was approved by the NCI on August 20, 2007. RTOG will activate this study (open it for patient enrollment) on October 19, 2007. RTOG will broadcast on that date to notify institutions that the study is open to accrual. Important: RTOG strongly encourages investigators to complete the pre-registration requirements for the study (see Section 5.1 of the protocol) and to forward the protocol and forms to their site IRBs for review prior to the activation date. This is to notify sites that the QOL forms HP (Health Utility Measurement) and FA (Functional Assessment) are now available on the RTOG web site at http://www.rtog.org/members/forms/0617/main.html Please note that the study is NOT YET OPEN TO ACCRUAL. Please notify your affiliates who are not on e-mail. Web registration is available 24/7. Information and instructions available at https://silver2.phila.acr.org/Clinical_RTOG/pgIndex.html DATE: August 21, 2007 SUBJECT: RTOG 0617, Pre-Activation Notification Pre-Activation Notification RTOG 0617, “A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer” was approved by the NCI on August 20, 2007. RTOG will activate this study (open it for patient enrollment) on October 19, 2007. RTOG will broadcast on that date to notify institutions that the study is open to accrual. Important: RTOG strongly encourages investigators to complete the pre-registration requirements for the study (see Section 5.1 of the protocol) and to forward the protocol and forms to their site IRBs for review prior to the activation date. Institutions can download a copy of the NCI approved protocol for IRB review by accessing the RTOG web site at http://www.rtog.org/members/protocols/0617/0617.pdf Another broadcast will be sent in the near future when the case report forms are available on the RTOG web site. Please note that the study is NOT YET OPEN TO ACCRUAL. Please notify your affiliates who are not on e-mail.