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Date Broadcast
6/4/2013 3:38:08 PM Subject: Form Revision Notice - RTOG 1174

FORM REVISION
RTOG 1174

A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer
Compared to Chemoradiation Alone: The OUTBACK Trial (ANZGOG 0902/GOG-0274/RTOG 1174)


The Quality of Life Forms (QOLs) have been revised:
          Old Version   1.0                                        New version 1.1


Changes Made: Page# 8(of QOL booklet)   A sentence was added to the explanation/instruction section of the SVQ (Extended version) Sexual Function–Vaginal Changes Questionnaire.
 

Download the new version from the RTOG web site at:
http://www.rtog.org/LinkClick.aspx?fileticket=4yvpBbSe2HE%3d&tabid=290
 

Sites can begin to use the new version 1.1 immediately.  The use of any remaining 1.0 versions is permitted.

 

Debora Grant, RN, MSN
RTOG Data Management

 
5/14/2013 3:18:47 PM Subject: RTOG 1174 (OUTBACK), International Newsletter

Attention RTOG Investigators participating in RTOG 1174 (ANZGOG0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”

Please see the attached May 2013 edition of the OUTBACK International newsletter. This edition contains important information about nodal stratification, MRI reporting and QOL collection.
 
Also attached is a staging protocol that clarifies requirements for MRI reports.
 
Please notify your affiliates that are not on e-mail.
 
If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, send a message to
RTOG-UserAccounts@acr.org .  Sites should not reply directly to this broadcast .Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; click on the Contact Us button on the top right of the home page. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department.

 

- OUTBACK_international_newsletter__May13.pdf
5/14/2013 3:17:07 PM Subject: RTOG 1174 (OUTBACK), Amended

Amended

RTOG 1174 (ANZGOG 0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial” (Protocol, Group-Specific Study Handbook and Informed Consent)
 
Changes include:
Protocol:
·         Section 8 (Treatment) has been updated to clarify dosing requirements and dose modifications;
·         Section 9 (Summary of Assessment) has been updated to reflect that if a patient has had both a MRI of the pelvis and PET/CT at baseline, then a separate CT of the Chest/Abdo/Pelvis is not required; The timeframe for when baseline assessments should occur has been changed from within 4 weeks to within 6 weeks of randomization.
Group-Specific Study Handbook:
·         Section 3.1 (Randomization), the screen shots for the InForm system have been updated to conform with updates to the InForm system
·         Section 8 (SAE reporting) has been updated throughout to conform with updates to the InForm system
Group-Specific Informed Consent:
·         Administrative changes for clarity made throughout
See the complete summary of changes for the amendment via the RTOG web site at
 
RTOG sites can download a copy of the Group-Specific Study Handbookon the RTOG website at
 
RTOG sites can download a copy of the Group-Specific Informed Consenton the RTOG website at
 
RTOG Sites can download a copy of the protocol on the RTOG website at http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?action=openFile&FileID=10105
NCI policy requires that the "Version Date" on the Group-Specific Study Handbookand Group-Specific Informed Consent reflect the date the amendment was submitted to NCI
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.
 
If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, send a message to RTOG-UserAccounts@acr.org. Sites should not reply directly to this broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select “Contact Us” at the top right of the home page. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department.
 
 
3/20/2013 Subject: RTOG 1174 Outback Trial - QOL Forms - NEW! Paper Version


RTOG 1174

A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial (ANZGOG 0902/GOG-0274/RTOG 1174)

Quality of Life Forms (QOLs) are now available in a PDF version and can be downloaded from the RTOG website via the RTOG 1174 forms page.

Download the new form from the RTOG web site at: http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1174&mode=html&ptid=383

Sites are permitted to use any remaining QOL booklets at their site or begin to use the new PDF versions with the next submission.

The process of QOL forms submission remains the same. The forms can be submitted via e-mail to the OUTBACK mailbox, (Outback@ctc.usyd.edu.au) or via postal mail service, to the following address:
                                                                                                
The Outback Trial                                                     The Outback Trial
NHMRC Clinical Trials Centre        OR                    NHMRC Clinical Trials Centre      
Locked Bag 77                                                         Level 2, 10 Mallett St
Camperdown NSW 2050                                         Camperdown NSW 2050
Australia                                                                   Australia
                                                                          (This address used for courier services)

DO NOT SUBMIT QOL FORMS TO RTOG

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

 

RTOG Data Management


 
2/20/2013 Subject: OUTBACK Trial Database - Unavailable Fri 22 Feb 8am to Mon 25 Feb 8am Australian Time


Dear All,

Please be aware that the OUTBACK trial database will be taken off-line to implement scheduled updates from Friday 22 Feb 8am Australian Eastern Time to Monday 25 Feb 8am Australian Eastern Time.

During this period it will not be possible to randomise patients or enter any data. Please randomise any patients before the database is taken off-line.

We apologise in advance for any inconvenience that this may cause. Once the database is available again, you will notice small changes to some of the forms. We will provide updated eCRF completion guidelines to go with the database updates.

 

 
2/14/2013 10:05:40 AM Subject: RTOG 1174 (the OUTBACK Trial) Trial Newsletter

Attention RTOG Investigators participating in RTOG 1174 (GOG-0274/ANZGOG0902), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”

 
Please see the attached February 2013 edition of the OUTBACK Trial Newsletter for important trial updates.
 
Please notify your affiliates that are not on e-mail.
12/20/2012 9:09:49 AM Subject: RTOG 1174, Updated Us Group Specific Study Handbook

Updated

The US Group-Specific Study Handbook for
 
RTOG 1174 (ANZGOG 0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”
 
  • Section 3.1: A Note for RTOG non-US members has been added;
  • Section 7.3: The process for when and how an RTOG site will receive QOL booklets has been updated;
  • Other administrative changes for clarity have been made throughout.
 
 
RTOG sites can access the updated US Group-Specific Study Handbook at http://www.rtog.org/LinkClick.aspx?fileticket=DqaB7indamQ%3d&tabid=290

IRB review of an update is not required; however, these changes must be reported to site IRBs.
12/11/2012 8:44:23 AM Subject: RTOG 1174 (OUTBACK TRIAL) International Newsletter

Attention RTOG Investigators participating in RTOG 1174 (GOG-0274/ANZGOG0902), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”

Please see the attached December 2012 edition of the OUTBACK International newsletter for important trial updates.
 
Please notify your affiliates that are not on e-mail
11/13/2012 9:14:37 AM Subject: RTOG 1174 (OUTBACK) Important Trial Memo

Attention RTOG Investigators participating in RTOG 1174 (ANZGOG0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”.

Please see the attached memo with important reminders for SAE reporting to ANZGOG.
Please notify your affiliates that are not on e-mail.
If you would like to be added or removed from the RTOG broadcast list or wish to update your e-mail address, send a message to RTOGUserAccounts@acr.org. Sites should not reply directly to this broadcast .Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at www.rtog.org; select Contact Us at the top right of the home page. Sites also can call 1-800-227-5463, ext. 4189, which provides prompts to reach each department
10/9/2012 9:43:07 AM Subject: RTOG 1174 (OUTBACK Trial), International Newsletter

Attention RTOG Investigators participating in RTOG 1174 (ANZGOG0902/GOG-0274), “A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The OUTBACK Trial”

 
Please see the attached October 2012 edition of the OUTBACK International newsletter for important trial updates.
 

Please notify your affiliates that are not on e-mail

- OUTBACK_international_newsletter__Oct12.pdf

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