July 25, 2016

ACTIVATIONS
GYNECOLOGIC
GOG-0279: Reactivation effective July 25, 2016; Version date: April 10, 2014.

AMENDMENTS AND UPDATES
HEAD & NECK
RTOG-1010: Amendment 5 dated June, 13, 2016 has been approved by Health Canada. Sites in Canada can find the NOL and required TPD forms on the CTSU website.

GASTROINTESTINAL
RTOG 0848: Study Memorandum dated July 25, 2016; also available on the CTSU website.

RTOG-0848: Amendment 6 dated June, 28, 2016 has been approved by Health Canada. Sites in Canada can find the NOL and required TPD forms on the CTSU website.

GENITOURINARY
NRG-GU001: Amendment 3; Version Date: June 13, 2016; available on the CTSU website.

OTHER PROTOCOL NOTICES
GYNECOLOGIC
GOG-0274/RTOG 1174: Memo: Data Chase for ‘follow up’ assessments and associated QOL Questionnaires.

NRG-GY004: Memo: Chest Imaging. See CTSU website.

NRG-GY004 and NRG-GY005
: Memo: Study-Specific 1572s and COI No Longer Required and New Process for Firecrest Access. See CTSU website.

NRG-GY004 and NRG-GY005
: Memo: Revised Dates for SIV Training. CTSU website.

NRG-GY004 and NRG-GY005: Investigator Meeting slides from the July 15, 2016 NRG Oncology meeting in Dallas, are now available on the CTSU website.

LUNG
RTOG 1308: Informational videos on this trial are now available on our new Patient Resources page on the NRG Oncology website.

Vision Tree Webinar
The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, NRG-HN001, and NRG-HN002. Space is limited so register now and reserve your seat. The next webinar training is scheduled for August 10, 2016.

DRUG SAFETY UPDATES AND INVESTIGATOR BROCHURE (IB) NOTICES
Safety updates have been issued for NSABP legacy studies. For details, please see the NSABP Members’ Area or the Email Distributions page and the CTSU website.

The Pharmaceutical Management Branch (PMB) has issued an updated IB for the following NRG Oncology studies:
-Nivolumab: NRG-BN002, NRG-GY002, NRG-GY003
All investigator’s receiving this agent from PMB for an NCI-sponsored trial have already received a copy of this IB directly from PMB. Contact PMB at IBCOORDINATOR@MAIL.NIH.GOV to obtain a copy of this IB.

Please take our brief SURVEY to let us know what types of topics you would like to see included in our NRG Oncology communications.

NRG Oncology is pleased to report the scientific articles and abstracts that have appeared or have been presented during the previous week. This publications report includes links, when available, to the article, PubMed abstract, or association abstract.

JOURNAL ARTICLES
Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4. PubMed PMID: 27044935. Read more

Li XA, Chen X, Zhang Q, Kirsch DG, Petersen I, DeLaney TF, Freeman CR, Trotti A, Hitchcock Y, Bedi M, Haddock M, Salerno K, Dundas G, Wang D. Margin reduction from image guided radiation therapy for soft tissue sarcoma: Secondary analysis of Radiation Therapy Oncology Group 0630 results. Pract Radiat Oncol. 2016 Jul-Aug;6(4):e135-40. doi: 10.1016/j.prro.2015.11.012. Epub 2015 Nov 17. PubMed PMID: 26852173; PubMed Central PMCID: PMC4870138. Read more

Mak RH, Hunt D, Efstathiou JA, Heney NM, Jones CU, Lukka HR, Bahary JP, Patel M, Balogh A, Nabid A, Leibenhaut MH, Hamstra DA, Roof KS, Jeffrey Lee R, Gore EM, Sandler HM, Shipley WU. Acute and late urinary toxicity following radiation in men with an intact prostate gland or after a radical prostatectomy: A secondary analysis of RTOG 94-08 and 96-01. Urol Oncol. 2016 Jul 2. pii: S1078-1439(16)30049-7. doi: 10.1016/j.urolonc.2016.04.015. [Epub ahead of print] PubMed PMID: 27381895. Read more

Divi V, Harris J, Harari PM, Cooper JS, McHugh J, Bell D, Sturgis EM, Cmelak AJ, Suntharalingam M, Raben D, Kim H, Spencer SA, Laramore GE, Trotti A, Foote RL, Schultz C, Thorstad WL, Zhang QE, Le QT, Holsinger FC. Establishing quality indicators for neck dissection: Correlating the number of lymph nodes with oncologic outcomes (NRG Oncology RTOG 9501 and RTOG 0234). Cancer. 2016 Jul 15. doi: 10.1002/cncr.30204. [Epub ahead of print] PubMed PMID: 274198. Read more

PUBLICATIONS REMINDERS
Please note the following upcoming meeting and abstract submission deadline dates.

Upcoming Meetings
American Association of Physicists in Medicine (AAPM); Jul 31-Aug 4, 2016; Washington DC

Upcoming abstract submission deadlines
American Society for Radiation Oncology (ASTRO); Sep 25-28, 2016; Boston, MA; late-breaking abstract submission deadline; WednesdayAug 3, 2016

European Society for Medical Oncology (ESMO); Oct 7-11, 2016; Copenhagen, Denmark; meeting abstract submission deadline Aug 23, 2016 LBA

Society of Clinical Research (SOCRA); Sep 30-Oct 2, 2016; Montreal, QC, Canada; meeting abstracts submission deadline Jul 29, 2016

NRG Oncology is proud to be an active participant of #CancerMoonShot.

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