i For Protocol Update of: NRG-HN001, Randomized Phase II and

For Protocol Update of: NRG-HN001, Randomized Phase II and Phase III Studies of Individualized
Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV)
Deoxyribonucleic Acid (DNA)
NCI/Local Protocol #: NRG-HN001/NRG-HN001
NCI Protocol Version Date: March 17, 2014 (Update broadcast: 4/8/14)
Section
Global
Title pages
3.0
5.4
5.5
5.6.1
6.7
7.0
10.0
12.0
12.1
Appendix IV
Change
“Radiation Therapy Oncology Group”, “RTOG Headquarters”, and “RTOG” were
replaced with “NRG Oncology” or deleted, as appropriate, throughout the protocol.
 On the 2nd title page, the broadcast dates of pre-activation and this update
were added to the Document History table.
 On the 3rd title page, the table was updated to current CTSU standard text.
The 2nd sentence was updated to current standard text.
This section was updated to current standard text.
In the 2nd paragraph, “RTOG Biospecimen Resource” was replaced with “NRG
Oncology Biospecimen Bank”.
 In the 2nd paragraph, the parenthetical phrase, “RTOG and CTSU Sites”,
was deleted to update the section to current standard text.
 In the 4th paragraph, the 3rd bulleted item was updated to current standard
text.
 In the 4th paragraph, the last bulleted item was deleted to update the section
to current standard text.
In the 2nd row of the table, a subscript next to “PTV_6996” was deleted, as it was
redundant.
The 1st paragraph was deleted to update the section to current standard text.
Throughout this section, the “RTOG Biospecimen Resource” was updated to the
“NRG Oncology Biospecimen Bank”.
The 2nd paragraph was updated to current standard text.
 The 1st paragraph was updated to current standard text.
 In the 2nd paragraph, the forms were specified for AE reporting.
 The table was added to update the section for Rave.
Throughout this appendix, the “RTOG Biospecimen Resource” was updated to the
“NRG Oncology Biospecimen Bank”.
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