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RTOG 1005 Broadcasts

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Date Broadcast
8/18/2014 Subject: RTOG 1005, Amended

RTOG 1005 (closed), Amendment 4: NCI Version Date: 7/31/2014.

Amendment 4: On the first title page, a sentence was added beneath the title specifying NRG Oncology as leading the trial with participation of the network of NCTN researchers: the Alliance, ECOG-ACRIN, and SWOG.

Sites can access the complete summary of changes for the amendment at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=7947
 
 
NCI policy requires that the version date of the protocol reflect the date the amendment was submitted by NRG Oncology to NCI; for clarity, the version date (in bold) and the broadcast date of the amendment are provided in the Document History table on the 2nd title page of the protocol.
 
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days of this broadcast. NRG Oncology recommends re-consenting patients per the site’s local IRB policy. Sites must submit IRB approval for the amendment to CTSU.
 
 
 
 
 
 
6/20/2014 9:56:30 AM Subject: RTOG 1005, Closure Notice

RTOG 1005 Closure Notice
As broadcast on June 2, RTOG 1005, “A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer,” will close to accrual at 5 PM EST today Friday, June 20, as it has met its accrual goal.

Reminder: Data collection and site IRB renewal for closed studies must continue until the study is terminated.

This message is being sent to NRG Oncology-identified contact PIs, LAPs PI, PIs, local PIs, lead RAs, co-lead RAs, and local lead RAs. Please share with all other staff who participate in NRG Oncology research as appropriate. A comprehensive list of broadcasts is available at: http://www.rtog.org/ClinicalTrials/Broadcasts.aspx

6/2/2014 Subject: RTOG 1005 Closure & Re-broadcasts of protocol activity

Attention NRG Principal Investigators and Lead RAs:

RTOG 1005 Closure Notice

RTOG 1005, “A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost Versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer,” will close to accrual on Friday, June 20th, as it will have met its accrual goal.

Re-Broadcast of RTOG Legacy Trial Activity Notifications

We have become aware that some sites have not received recent broadcasts related to RTOG legacy trial activity. Please see below for a list of recent protocol activity (protocol amendments, updates, activations, and dear investigator/patient letters). For more details, please refer to the study-specific links on the RTOG website.  All broadcasts, including safety reports and forms revisions, are also listed by date at the following link: http://www.rtog.org/ClinicalTrials/Broadcasts.aspx 

This message is being sent to NRG Oncology-identified contact PIs, LAPs PI, PIs, local PIs, lead RAs, co-lead RAs, and local lead RAs. Please share with all other staff at your institution who participate in NRG Oncology research as appropriate. 

 

5/29/14: RTOG 0848, “Dear Investigator” and “Dear Patient” Letters
5/13/14: RTOG 0631, Amended
5/7/14: RTOG 1008, Amended
5/1/14:  RTOG 96-01, 0126, 0232, 0415, 0521 Updated
5/1/14: RTOG 9813, Updated
5/1/14: RTOG 1005, Amended
5/1/14: RTOG 1205, Amended
5/1/14: RTOG 1122, Amended 
5/1/14: RTOG 0539, 0627, 0825, 0837 Updated
4/30/14: RTOG 0517, 0938 Updated
4/30/14: RTOG 0920, Amended
4/29/14: RTOG 0534 and 0815, Updated
4/29/14: RTOG 1112 and RTOG 1203, Updated
4/29/14: RTOG 0630, Amended
4/29/14: RTOG 1114, Amended
4/28/14: RTOG 0926, Amended
4/28/14: Amended: RTOG 0526, 0621
4/22/14: RTOG 0924, Amended
4/21/14: NRG-HN001, Activated
4/17/14: RTOG 1119, Updated
4/17/14: RTOG 1010, Updated
4/17/14: RTOG 1014, Amended
4/16/14: RTOG 95-12 and 0234, Amended
4/14/14: RTOG 0937, Amended
4/8/14: NRG-HN001, Pre-Activation for IRB Review
4/2/14: RTOG 0848, Re-opened, Amended and Updated
3/26/14: RTOG 1016, Updated
3/26/14: RTOG 1216, Amended
3/25/14: RTOG 1008, Updated
3/25/14: RTOG 0912, Updated
3/24/14: RTOG 0617/NCCTG N0628/CALGB 30609/ECOG R0617, Amended
3/20/14: RTOG 0839, Amended
3/19/14: RTOG 0618, 0813, 0915, Amended
3/17/14: RTOG 0913, Action Letter and Amendments 4-5
3/13/14: RTOG 1106/ACRIN 6697, Amended and Updated
3/6/14: RTOG 0929, Action Letter and Amendment 

This message is being sent to NRG Oncology-identified contact PIs, LAPs PI, PIs, local PIs, lead RAs, co-lead RAs, and local lead RAs. Please share with all other staff who participate in NRG Oncology research as appropriate. A comprehensive list of broadcasts is available at: http://www.rtog.org/ClinicalTrials/Broadcasts.aspx

5/14/2014 3:06:41 PM Subject: RTOG 1005 Credentialing Update

CREDENTIALING UPDATE

 
RTOG 1005 –  “Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early Stage Breast Cancer”  will soon meet its  accrual objective.
 
New benchmark plans will no longer be accepted for credentialing as of COB Tuesday, May 20,2014.  Benchmark plans already in the credentialing process will be reviewed.
5/1/2014 9:19:19 AM Subject: RTOG 1005, Amended

 Amended

RTOG 1005, “A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost Versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer”

 

Amendment 3: The contact information for the Study Chair, Frank A. Vicini, MD, was updated to his current institution; all RTOG terminology has been revised to NRG Oncology terminology where applicable and additional references to RTOG have been removed where no longer applicable throughout the protocol; In addition, references to the “Adverse Event Reporting System (AdEERS)” were changed to “CTEP Adverse Event Reporting System (CTEP-AERS)”

 

Sites can access the complete summary of changes for the amendment at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=7947 

        

Sites can download a copy of the protocol for IRB review at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=9366

        

NCI policy requires that the version date of the protocol reflect the date the amendment was submitted by NRG Oncology to NCI; for clarity, the version date (in bold) and the broadcast date of the amendment are provided in the Document History table on the 2nd title page of the protocol.

 

Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days of this broadcast.  NRG Oncology recommends re-consenting patients per the site’s local IRB policy. Sites must submit IRB approval for the amendment to CTSU.

 

Please notify your affiliates that are not on e-mail.

 

4/1/2014 10:46:01 AM Subject: RTOG 1005 - CF Form Completion Instructions

                                                                                                 RTOG 1005

                  A PHASE III TRIAL OF ACCELERATED WHOLE BREAST IRRADIATION
             WITH HYPOFRACTIONATION PLUS CONCURRENT BOOST
        VERSUS STANDARD WHOLE BREAST IRRADIATION
                            PLUS SEQUENTIAL BOOST FOR EARLY-STAGE BREAST CANCER               

The information that you are asked to provide on this form is based on documentation found in the medical record for the indicated time point.  For example, baseline refers to study entry time point. 

There is no expectation that lab work will be performed to satisfy the baseline lab questions. Review of the medical record may  or may not contain the information requested.

The form will appear at the protocol specified time points on the calendars of patients who were enrolled prior to the addition of
this form. However, this initial submission will not affect delinquency scores if submitted by June 30th, 2014. 

Web-based data submission is mandatory. For technical support with web data submission, please e-mail websupport@acr.org.

Please notify your satellite institutions and affiliates who are not on our broadcast e-mail.


Data Management

 Web registration is available 24/7. Information and instructions available at
    https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

 

3/31/2014 3:46:06 PM Subject: RTOG 1005 - CF Form - Co-Morbidities and Other Conditions Form

RTOG 1005

A PHASE III TRIAL OF ACCELERATED WHOLE BREAST IRRADIATION
      WITH HYPOFRACTIONATION PLUS CONCURRENT BOOST
         VERSUS STANDARD WHOLE BREAST IRRADIATION
  PLUS SEQUENTIAL BOOST FOR EARLY-STAGE BREAST CANCER

The following form for this study has been revised.  Download the new version from the RTOG web site at:
http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1005&mode=html&ptid=383

The edition code for case report forms is found in the lower right corner of the form.

Form Type                                                                           Version Code/Date

CF Co-Morbidities and Other Conditions Form                       CFa       03/31/14

Changes Made:  Time point added on form.  For question #2 – N/A added as option.

This form is currently available for web data submission- Please complete this form for the time points designated in section 12.0 of the protocol.

The form will appear at the protocol specified time points on the calendars of patients who were enrolled prior to the addition of this form.  However, this initial submission will not affect delinquency scores if submitted by June 30th, 2014. 

Please discard obsolete versions and commence use of the revised edition immediately.

Web-based data submission is mandatory. For technical support with web data submission, please e-mail websupport@acr.org

Questions regarding information that is collected on the forms should be directed to Data Management at 215-574-3214.

Please notify your satellite institutions and affiliates who are not on our broadcast e-mail.


Data Management

Web registration is available 24/7. Information and instructions available at
https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

 

1/9/2014 Subject: RTOG 1005, Update and chemotherapy cosmesis subset closed

Update and Closure Notice for chemotherapy cosmesis subset

RTOG 1005, “A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost Versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer”
 
RTOG 1005 has a cosmesis component that will be analyzed separately for patients based on intention to receive chemotherapy, as indicated at the time of study entry. 
The cosmesis subset for patients receiving chemotherapy has met its accrual and is now closed to accrual.
NOTE: The cosmesis subset for patients not receiving chemotherapy closed to accrual on March 8th, 2013. Therefore, the entire cosmesis component for RTOG 1005 is now closed to accrual
RTOG 1005 as a whole is still accruing.
 
Update
The protocol and consent have been updated accordingly to support the closure to accrual for the cosmesis component.
 
Sites can access the complete summaries of changes for the update at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=7947
 
 
The broadcast date of the update is provided in the Document History table on the 2nd title page. IRB review of an update is not required; however, these changes must be reported to site IRBs.
 
Please notify your affiliates that are not on e-mail.
11/25/2013 10:21:32 AM Subject: TOG 1005: Correction to protocol posted for Amendment 2/Update 10.21.13

Attention RTOG 1005 Investigators:


The bulleted paragraph and the AE reporting table under the heading “AdEERS REPORTING REQUIREMENTS” in Section 6.11.1 and the entire Section 6.11.2 were inadvertently removed from the final version of the protocol that was posted for Amendment 2/Update 10.21.13 of RTOG 1005 (broadcast date: October 21, 2013).

 
 
No changes to the tracked protocol, sample consent, or content of the summary of changes were made with this correction.
 
______________________________________________________________________________________________________________________
 
From: RTOGBroadcast
Sent: Monday, October 21, 2013 2:03 PM
Subject: RTOG 1005, Amended and Updated
 
RTOG 1005, “A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation plus Concurrent Boost Versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer”
 
Amendment 2: Eligibility: Mammography requirement was simplified and the timeframe of last surgery (breast or axilla) and completion of chemotherapy relative to study entry was clarified. Section 4: bone scan assessments were revised; assessments for CT of chest/abdomen and pelvis or PET/CT were revised for clarity. Section 6.4: dose volume constraints for both Arm 1 and Arm 2 were simplified for clarity. Section 10.2: tumor tissue submission requirements were clarified; other various updates and clarifications were made throughout.
 
Update: RTOG is now using TRIAD to collect RT digital data. TRIAD provides sites participating in RTOG clinical trials with a secure method to transmit DICOM RT and other digital data. TRIAD anonymizes and validates the images and information objects as they are transferred via the internet. The protocol was updated to include logistics for TRIAD; other various administrative changes were made throughout
 
See the complete summary of changes for this amendment and update at
 
Sites can download a copy of the protocol and consent by accessing the RTOG website at:
(protocol)
 
(consent)
 
NCI policy requires that the version date of the protocol reflect the date the amendment was submitted by RTOG to NCI; for clarity, the version date (in bold) and the broadcast date of the amendment and update are provided in the Document History on the title page of the protocol.
 
Per CTMB Guidelines, amendments must be submitted and approved by local IRBs within 90 days of this broadcast.  RTOG recommends re-consenting patients per your local IRB policy. Sites must submit IRB approval for the amendments to CTSU.
 
 
Please notify your affiliates that are not on e-mail.
11/8/2013 3:44:20 PM Subject: Form Revision Notice - RTOG 1005


RTOG 1005


A Phase III Trial Of Accelerated Whole Breast Irradiation With Hypofractionation Plus Concurrent Boost
Versus Standard Whole Breast Irradiation Plus Sequential Boost For Early-Stage Breast Cancer
 

                                                                                         Form Revision
The I1 form for this study has been revised and a new Co-morbidities (CF) form added.  Download the new versions from the RTOG web site at: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1005&mode=html&ptid=383

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 10/21/13                                         
              CF   Co-morbidities and Other Conditions Form                                  CF  10/21/13

Changes Made:  The date on the forms is located on the lower right corner of the form. These have been updated  to reflect the date of the broadcast of the amended protocol - 10/21/2013

                      CF:   New Form

                      I1: 1. Q#11 Margin question updated to reflect new updated protocol section 3.1.6
                           2. Q#17 AJCC Pathologic question…Parentheticals added
                               Low risk question updated to reflect new section 3.1.3A
                               History of prior invasive cancer question - updated  to read “Non-breast” 
                               malignancy
                               DCIS questions updated to include the word “only”
                               Pregnancy question updated to include “urine” test
                               Clinical Distant Mets question added
                               Bilateral Breast Cancer question added

Please notify your satellite institutions and affiliates who are not on e-mail.


RTOG Data Management

Web registration is available 24/7. Information and instructions available at
https://clinicalweb1.phila.acr.org/ClinicalRtog/faces/jsp/index.jsp

 

 

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