|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.
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:
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.