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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

 

 

10/21/2013 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.
9/30/2013 Subject: RTOG 1005 anticipated switch to TRIAD for Oct 2013

Attention RTOG 1005 Investigators and Research Associates: 

RTOG 1005 is in the process of being amended to add TRIAD as the means of submission for RT digital data. This change is expected to go into effect at the end of October. Please watch for the amendment broadcast.
 
In preparation for this change we are asking all sites that participate in this trial to complete the following steps:
 
Required:
1.     Site staff who will transmit RT imaging data (i.e. medical physicists & dosimetrists) will need to have an active CTEP-IAM user name and password. 
2.     Update your site roster on the CTSU members website to include your medical physics and dosimetry staff and assign them TRIAD site user role
3.     Submit an RTOG Roster Update Form to add staff with this role to your RTOG roster: http://www.rtog.org/LinkClick.aspx?fileticket=q61ShTwNbFQ%3d&tabid=308
4.     Site installs TRIAD on site computer. Information on this step will be available on the RTOG website under the Core Lab tab.
 
For TRIAD-specific questions, contact TRIAD-Support@acr.org or 1-703-390-9858. For other related questions, contact Tammy McGlade at tmcglade@acr.org
3/20/2013 Subject: RTOG 1005 - Reminder - 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”

Per the previous Broadcast on March 6th, please note that patients enrolling on this study who will not be receiving chemotherapy prior to radiation therapy cannot participate in the cosmesis subset of this study.

Thank you.

 

 

3/6/2013 11:55:59 AM Subject: RTOG 1005, closure notice for the non-chemotherapy cosemesis subset

Closure notice for non-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 not receiving chemotherapy has met its accrual and will be closed to further enrollment at close of business on Friday March 8th, 2013.   This closure date will be noted in the next protocol amendment.
The cosmesis subset for patients that are receiving chemotherapy will continue to accrue until its target is met.
Please note that this closure broadcast is for the non-chemotherapy cosmesis subset only.  The study as a whole is still accruing
12/4/2012 Subject: RTOG 1005 Frequently Asked Questions Page


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

A Frequently Asked Questions Page is now available for protocol 1005.  The page can be accessed using the following link below:

http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1005&mode=html&ptid=391

Debora Grant, RN/Wendy Bergantz, RN

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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