March 21, 2016

AMENDMENTS AND UPDATES
BRAIN
RTOG 1205: Study memorandum regarding error in sample consent, dated March 18, 2016


GYNECOLOGIC
GOG-0225: Amendment 6, Version Date: February 19, 2016

GOG-0281: Amendment 7, Version Date: February 23, 2016

GOG-9929: Action Letter and Amendment 5, Version Date: February 24, 2016

NRG-GY002: Action Letter and Amendment 1, Version Date: March 7, 2016

NRG-GY003: Action Letter and Amendment 3, Version Date: February 23, 2016

HEAD AND NECK

RTOG 0234:
Amendment 9 has been approved by Health Canada. Sites in Canada can access the NOL and TPD forms RTOG website

RTOG 0522: Amendment 10 has been approved by Health Canada. Sites in Canada can access the NOL and TPD forms CTSU website

RTOG 1008: Amendments 8-9 have been approved by Health Canada. Sites in Canada can access the NOL and TPD forms CTSU website

FORM UPDATES
NRG CC001:
The RAVE SOC (Standard of Care) form for the MRI imaging portion of the protocol and the updated Data Submission form may be found on the NRG website

OTHER PROTOCOL NOTICES
BREAST
NSABP B-55/BIG 6-13: OlympiA Newsletter, 4th Issue (posted to CTSU)

GYNECOLOGIC

NRG-GY004 and NRG-GY005
: NEW DATES ADDED for mandatory toxicity management SIVs. Please see the memo on the CTSU website for details.

Vision Tree Webinar
The
VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, RTOG 0928, NRG-HN001 and NRG-HN002. Space is limited so register now and reserve your seat. The next webinar training is scheduled for April 13, 2016.

DRUG SAFETY UPDATES
Safety updates have been issued for GOG legacy studies. For details, please see the GOG Weekly Mailing page.

Safety updates have been issued for NSABP legacy studies. For details, please see the NSABP Members’ Area or the E-mail Distributions page and the CTSU website.

Safety updates have been issued for the following NRG Oncology studies:

Nivolumab: NRG-GY002, NRG-GY003, NRG-BN002

Ipilimumab: NRG-GY003, NRG-BN002

For NRG-GY002 and NRG-GY003 safety reports, please see the protocol page on the NRG Oncology website for details.

For NRG-BN002 safety reports, please see the RTOG General Broadcast page for details.

HOLIDAY CLOSURES
The NRG Biospecimen Bank in San Francisco will be closed with limited staffing on Friday, March 25th in observance of UCSF Cesar Chavez Sr. holiday. For urgent matters on this day, please email the bank at NRGBB@ucsf.edu as we will be checking and replying to emails only. Please contact us at NRGBB@ucsf.edu or 415-476-7864 with any questions regarding this closure.

The NHMRC Clinical Trials Centre will be closed on Friday, March 25 and Monday, March 28, 2016 due to the Good Friday and Easter Monday public holidays. See memo for details.

UPCOMING MEETINGS
American Association for Cancer Research (AACR); Apr 16-20, 2016, New Orleans, LA

American Association of Neurological Surgeons (AANS); Apr 30-May 4, 2016, Chicago, IL

American Radium Society (ARS); Apr 16-19, 2016, Philadelphia, PA

American Society of Colon and Rectal Surgeons (ASCRS); Apr 30-May 4, 2016, Los Angeles, CA

American Society of Breast Surgeons (ASBS); Apr 13-16, 2016, Dallas, TX

European Society for Radiotherapy and Oncology (ESTRO); Apr 29-May 3, 2016, Turin, Italy

Western Association of Gynecologic Oncologists (WAGO); Jun 8-11, 2016, Sedona, AZ

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