December 26, 2018
NRG Oncology Broadcast archives are accessible from our website at any time. Please bookmark  this link  for your convenience.

James Dignam, PhD
Time to Biochemical Failure Could be Used as a Surrogate Endpoint in Treatment of Locally Advanced Prostate Cancer
Read more in News.

Our NRG Oncology Semiannual Meeting registration fee is waived, but we still need you to register today!  Read more 
 

Help Celebrate Our Birthday at the NRG Oncology Semiannual Meeting in Phoenix
We hope you can join us for the NRG Oncology Semiannual Meeting and Birthday Celebration, February 7-9, 2019, at the Phoenix Convention Center in Phoenix, AZ. 
Registration deadline is January 14, 2019!

 
Our Gift to You

It’s our birthday, and we are celebrating the reason for our success – our members! We are extending our birthday gift to you. In honor of our 5th birthday, NRG Oncology is waiving the registration fee for all NRG Oncology members - but we still need you to  click here to register today!


AMENDMENTS

GYNECOLOGIC

GOG-0262: Amendment 11; version date: November 7, 2018 (posted on CTSU)

 

LUNG

NRG-LU001: Amendment 3; version date: November 1, 2018 (posted to NRG Oncology)

 

RTOG 1106: Attention sites in Canada – Health Canada reviewed Amendments 9-10 and determined the changes can be processed as a notification; therefore, a NOL is not required. Sites may proceed with IRB/REB submission.

 

FORM UPDATES

HEAD & NECK

NRG-HN001: The EBV DNA Specimen Transmittal form has been revised and is available on the CTSU website. Use the revised version date (December 13, 2018) immediately.


OTHER PROTOCOL NOTICES
1.   BREAST

NRG-BR002: Kuhn-Hicks Laboratory New Year's Holiday Closure
New Year's holiday closure information for the Kuhn-Hicks Laboratory is posted on the NRG Oncology website.

2.   CANCER PREVENTION AND CONTROL

NRG-CC004:  Patient-reported outcomes (PROs) are an integral part to CC004 and the success of the trial depends on timely completion of these forms. Please make sure that patients are completing all PRO assessments within the protocol-specified time windows located in Section 4. Please also note that the protocol specifies data collection at weeks 1, 2, 5, 7, and 9 during protocol treatment. Sites are responsible for obtaining the dosing and toxicity information for weeks 3 and 4 during the week 5 check in, for week 6 during the week 7 check-in and for week 8 during the week 9 check-in. This is because all dosing and toxicity data during treatment must be reported. Typically this information would be asked at the end of treatment, but it is being collected according to the PRO-CTCAE assessment schedule for ease.

3.   GYNECOLOGIC

NRG-GY007: The Catalent holiday shipping schedule and an updated drug request form (to reflect new drug lot) have been posted on the NRG-GY007 page of the Clinical Trials Table on the NRG Oncology website. Please be advised that the current lot of ruxolitinib will be expiring January 2019.  All expired drug is to be destroyed as per institutional policy and recorded on the DARF. 

 

Form TR for Biospecimens Shipped to NRG Biospecimen Bank-Columbus

Please note that the NRG Patient ID (e.g., AB###-GY###-#####) must be included on any copies of Form TR shipped to the NRG Biospecimen Bank-Columbus. If the NRG Patient ID does not appear on the top, left of Form TR, please hand-complete the NRG Patient ID before sending the form to the NRG Biospecimen Bank-Columbus. Do not complete the NRG Patient ID for forms accompanying biospecimens shipped laboratories other than the NRG Biospecimen Bank-Columbus. Please contact the NRG Biospecimen Bank-Columbus at bpcbank@nationwidechildrens.org if you need assistance or if you have additional questions.

 

Biospecimen Bank-Columbus & SDMC Undergoing Refurbishment

Please be advised that the data exchange between the Biospecimen Bank-Columbus and SDMC is undergoing refurbishment. During this time, biospecimen receipt information will not appear in Rave or SEDES.


Biospecimen transmittal forms (i.e., Form SP and Form TR) will ultimately not appear as overdue during this time; however, there may be a brief period over the next several weeks during which forms may temporarily appear as overdue. If this should occur or if you experience any other issues, please notify Support at support@nrgoncology.org. Sites should continue to return inquiries from Biospecimen Bank-Columbus staff regarding biospecimen receipt during this time.

 

4. VTOC TRAINING

The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on RTOG 0924, RTOG 0920, NRG-HN001, NRG-HN002, NRG-CC003, and NRG-CC004. Space is limited so register now and reserve your seat. The next webinar training is scheduled for February 7, 1pm MST, at the NRG Oncology Semiannual Meeting.


 

 

DRUG SAFETY UPDATES AND INVESTIGATOR'S BROCHURE NOTICE

 

Safety updates and an Investigator’s Brochure notice have been issued for the following studies:

DRUG NAME

PROTOCOL

WEBSITE FOR

SAFETY REPORTS

INVESTIGATOR'S BROCHURE (IB)

Cabozantinib

NRG-GY001

CTSU

 

Durvalumab

NRG-HN004

 

X *

Nivolumab

NRG-BN002

NRG-GY003

NRG

NRG

 

Trametinib

GOG-0281

CTSU

 

 
* The current version of the Investigator Brochure Documents for Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI)-sponsored trials are available for access via the Cancer Therapy Evaluation Program (CTEP) Online Agent Order Processing (OAOP) website ( https://ctepcore.nci.nih.gov/OAOP/).  Log-in using your Identity and Access Management (IAM) username and password credentials and provide the requested information to access the document.

Every site principal investigator is responsible for reviewing this document. The Investigator Brochure is for use by the site principal investigator and any study personnel under his/her supervision who need to know the contents for the conduct of a clinical trial, including Institutional Review Board(s) or Independent Ethics Committee(s).

 

Time to Biochemical Failure Could be Used as a Surrogate Endpoint in Treatment of Locally Advanced Prostate Cancer

An analysis of the NRG Oncology clinical trial NRG-RTOG 9202 showed that the interval of time to biochemical failure (IBF), or the time it takes for previously treated cancer to return as indicated by prostate specific antigen (PSA) rise, could be used as a surrogate endpoint for locally advanced prostate cancer. Previously, surrogate endpoints based on PSA, which are alternate endpoints that could determine the effectiveness of a treatment earlier than traditional clinical endpoints, have been tested and evaluated with radiotherapy and short-term androgen deprivation. However, surrogate endpoints for long-term androgen deprivation, a proven therapy in high-risk, localized cancers, have not been investigated. The results of this analysis are published in the Journal of Clinical Oncology. Read the press release.

 

Join the Head and Neck Cancer Alliance in Celebrating the 2019 Oral, Head and Neck Cancer Awareness Week®, April 7-14

The Head and Neck Cancer Alliance (HNCA) is hosting its Annual Oral, Head and Neck Cancer Awareness Week®, OHANCAW, April 7-14, 2019, and is looking to another record-setting year. If you have not already done so, please be sure to register your screening site today! Since the institution of OHANCAW, hundreds of thousands of people worldwide have undergone free screenings and many lives have been saved through early detection and treatment. It is a simple and easy process to host a screening event in your local community. HNCA provides the materials and the screening sites organize the staff and volunteers. Read more

New Year's Holiday Closures

New Year's holiday closure information for the NRG Oncology Operations Offices and Statistics and Data Management Centers (SDMCs), Biospecimen Banks, and McKesson Clinical Research Services is posted on the NRG Oncology website under "News; 2018 Announcements."

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

Bertagnolli MM, Blaney SM, Blanke CD, Curran WJ, Dancey J, Mannel RS, O'Dwyer PJ, Schnall MD, Wolmark N; Coalition of Cancer Cooperative Groups. Current Activities of the Coalition of Cancer Cooperative Groups. J Natl Cancer Inst. 2018 Dec 13. [Epub ahead of print] PubMed PMID: 30544145. Read more

Mamounas EP, Bandos H, Lembersky BC, Jeong JH, Geyer CE Jr, Rastogi P, Fehrenbacher L, Graham ML, Chia SK, Brufsky AM, Walshe JM, Soori GS, Dakhil SR, Seay TE, Wade JL 3rd, McCarron EC, Paik S, Swain SM, Wickerham DL, Wolmark N. Use of letrozole after aromatase inhibitor-based therapy (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2018 Nov 30. pii: S1470-2045(18)30621-1. [Epub ahead of print] PubMed PMID: 30509771. Read more

Seidman AD, Bordeleau L, Fehrenbacher L, Barlow WE, Perlmutter J, Rubinstein L, Wedam SB, Hershman DL, Hayes JF, Butler LP, Smith ML, Regan MM, Beaver JA, Amiri-Kordestani L, Rastogi P, Zujewski JA, Korde LA. National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.  J Clin Oncol. 2018 Nov;36(32):3259-3268. Epub 2018 Sep 13. PubMed PMID: 30212295. Read more

Zhang QE, Wu Q, Harari PM, Rosenthal DI. Randomized phase II/III confirmatory treatment selection design with a change of survival end points: Statistical design of Radiation Therapy Oncology Group 1216. Head Neck. 2018 Dec 14. [Epub ahead of print] PubMed PMID: 30549358. Read more

PUBLICATIONS REMINDERS

Please note the following upcoming meeting and abstract submission deadline dates

Upcoming Meetings

American Association for Cancer Research (AACR); Mar 29 - Apr 3, 2019; Atlanta, GA

American Society of Clinical Oncology (ASCO) GI; Jan 17-19, 2019; San Francisco, CA

American Society of Clinical Oncology (ASCO) GU; Feb 14-16, 2019; San Francisco, CA

Society of Gynecologic Oncology (SGO); Mar 16-19, 2019; Honolulu, HI

Society of Surgical Oncology (SSO); Mar 27-30, 2019 ; San Diego, CA

St. Gallen Breast Cancer Conference (SG-BCC); Mar 20-23, 2019; Vienna, Austria

 

 

Upcoming Abstract Submission Deadlines

American Association for Cancer Research (AACR); Mar 29-Apr 3, 2019; Atlanta, GA; LBA submission deadline Jan 10, 2019

American Brachytherapy Society (ABS); Jun 13-15, 2019; Miami, FL; due to publications committee Dec 28, 2018; meeting submission deadline Jan 11, 2019 4pm CT

American Association of Physicists in Medicine (AAPM); Jul 14-18, 2019; San Antonio, TX; due to publications committee Feb 21, 2019; meeting submission deadline Mar 7, 2019

American Society of Clinical Oncology (ASCO); May 31-Jun 4, 2019; Chicago, IL; due to publications committee Jan 29, 2019; meeting submission deadline Feb 12, 2019; LBA Mar 14, 2019 12pm ET

American Society for Radiation Oncology (ASTRO); Sep 15-18, 2019; Chicago, IL; due to publications committee Jan 30, 2019; meeting submission deadline Feb 24, 2019

ESMO Breast Cancer Annual Congress; May 2-4, 2019; Berlin, Germany; due to publications committee Jan 16, 2019; meeting submission deadline Jan 30, 2019 TIP, LBA placeholder; noon CET (Central Europe Time); LBA deadline Apr 1, 2019 noon CEST (Central Europe Summer Time)

Society of Gynecologic Oncology (SGO); Mar 16-19, 2019; Honolulu, HI; deadline for LBA Jan 7, 2019

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