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April 15, 2024

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AMENDMENTS

BREAST

EAY191-N2 (ComboMATCH): Amendment 2; version date: February 12, 2024 (posted on CTSU)

 

GYNECOLOGIC

EAY191-N4 (ComboMATCH): Amendment 4; version date: March 27, 2024 (posted on CTSU)


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

NRG-GY022: Reminder: Actively Recruiting MALE Patients only Read More

 

2. BIOSPECIMEN BANKS

Important Reminder: San Francisco Biospecimen Bank (NRGBB-SF) database migration

The NRGBB-SF biospecimen database migration is occurring April 8-19, 2024. Due to this change, NRGBB-SF requests that institutions with the capacity to store their samples collected for biobanking, do so on-site. Please DO NOT ship samples to the NRGBB-SF bank between April 8-19, 2024.

  • During this time, NRGBB-SF will not provide routine return airbills for frozen shipments without prior authorization and will not be accepting large batch of international/domestic frozen specimens.
  • If your site cannot store frozen samples, please contact the bank for prior authorization to ship frozen samples.
  • Protocols with mandatory central review or fresh blood processing: These samples can be shipped at any time as usual; database change will not impede patient care or treatment.
  • FFPE samples are not affected by this change, sites may ship these as needed. Collection kits may be requested as usual.
  • Shipments to the Pittsburgh or Columbus bank are not affected by this change, shipments can be sent as usual. 


Printing Biospecimen Transmittal PDFs from Rave

Please note an effort is underway to clarify how to obtain a Biospecimen Transmittal PDF for submission to the NRG Oncology Biospecimen Bank. Read More


3. BREAST

NRG-BR007/DEBRA: Study overview webinars are being held via Microsoft Teams on April 19 from 2-3pm ET and April 26 from 12-1pm ET. Please see the memorandum, dated March 25, 2024, (posted on CTSU) for details and how to register for one of the sessions. Please note: Google Chrome is the preferred browser to register for the webinars. 

 

NRG-BR008/HERO: Study overview webinars are being held via Microsoft Teams on April 30 at 3pm ET and May 1 at 11am ET. Please see the memorandum, dated April 1, 2024, (posted on CTSU) for details and how to register for one of the sessions. Please note: Google Chrome is the preferred browser to register for the webinars.


4. CANCER PREVENTION & CONTROL

NRG-CC010: The study is now open to NRG sites in Japan and South Korea. The optional biospecimen collection does not apply to sites participating in these countries.


5. GENITOURINARY

NRG-GU011: Reminder! This phase II trial for patients with Oligometastatic Prostate Cancer is open to enrollment. The study is open to all NCTN member sites in the U.S and Canada. Please help us enroll. Protocol documents are posted on CTSU.


6. GYNECOLOGIC

GOG-0210: Reminder: Biospecimens, biomarker data, clinical data, and epidemiologic data are available for request. Please visit the NRG Oncology website for more information on this important study with the overall goal of improving the outcome and/or quality of life for patients with endometrial cancer.

 

NRG-GY031: Please note, there is an error in the section 4.2 table and the Biospecimen Collection and Submission Manual. The Part I PK collection is to be done on Cycle 1, Day 1, and Cycle 1, Day 8. This will be updated with the next amendment.


7. HEAD & NECK

NRG-HN008: Reminder - please update treatment and AE data weekly. This is a Phase I trial and timely data submission is very important. 


NRG-HN011: Reminder! The frozen baseline plasma EBV DNA and the frozen post-induction treatment plasma EBV DNA from each patient will be batch shipped together. Samples will be analyzed at the central lab towards the end of the study. For sites in the United States and Canada, kits can be requested from the NRG Oncology Biospecimen Bank by email nrgbb@ucsf.edu or using a kit request form at https://nrgbb.ucsf.edu/kits-collections


8. LUNG

NRG-LU005: As part of the additional data collection requirements, a “Status” field has been added to all Lab Results forms. This field indicates whether a result is normal or abnormal and must be completed for all lab tests. Leaving this field blank will result in additional queries. Please ensure this field is completed.

 

NRG-LU007: Pathology Correlatives Instructions; version date: March 20, 2024 (posted on CTSU)


9. VTOC TRAINING

The VTOC Webinar Training Series schedule and registration is available for NRG Oncology Research Associates working on NRG-HN001, NRG-HN002, NRG-CC003, NRG-CC005, NRG-BR009, NRG-CC011, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, May 8, 2024.

 

Drug Safety and Investigator’s Brochure (IB) updates have been issued for the following studies:

DRUG NAME

PROTOCOL

WEBSITE FOR SAFETY REPORTS

IB*

Atezolizumab

NRG-BN010

NRG-BR004

NRG-GI004/SWOG-S1610

NRG-GY009

NRG-LU002

NRG-LU005

NRG-LU007

RTOG 1216

CTSU

CTSU

CTSU

CTSU

CTSU

CTSU

CTSU

CTSU


Durvalumab

NRG-GY012

NRG-GY023

NRG-HN004

NRG-LU004

RTOG 1308

CTSU

CTSU

CTSU

NRG

CTSU


Olaparib

EAY191-N4

NRG-GY0004

NRG-GY005

NRG-GY012

NRG-GY021

NRG-GY023

NRG-GY029



X

X

X

X

X

X

X

*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) Agent Inventory Management System (AURORA) application. Log-in using your Identity and Access Management (IAM) or ID.me 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).

1. NRG Oncology Currents

The April issue of the NRG Currents eNewsletter is now available. This edition includes Head and Neck Cancer Awareness month featuring H&N cancer trials updates, the monthly PSC column, NCORP news, and more! Click here to view.

 

2. Application Deadline Extension - Chair, NRG Oncology Developmental Therapeutics Gynecologic Phase I Subcommittee

NEW Application Deadline: April 22, 2024.We are seeking nominations for the position of Chair, NRG Developmental Therapeutics Gynecologic Phase I Subcommittee. This NRG subcommittee sits within the NRG Developmental Therapeutics Committee, a Scientific Core Committee, and aides in cross-group collaboration and engagement around disease/target-oriented Phase I trials. Read more


3. Developing and Running an R01 Through NRG NCORP

Recording and slides from the April 11, 2024 webinar are available on the NRG NCORP webpage. 

 

4. Health Disparities Committee Symposium

The NRG Oncology Health Disparities Committee (HDC) will be hosting their annual symposium on Tuesday, April 16, 2024; 3-4:30pm ET. The focus of this year’s symposium will be “Aligning Clinical Trial Development with an Aging Population: Challenges and Opportunities for Older Adults with Cancer.” Refer to the agenda or the flyer for details. Please register in advance for this webinar. After registering, you will receive an email with the webinar link.

 

5. NRG Oncology Confidential Member Survey

Please read our survey FAQ’s. All NRG Members should have received an email from the University of Chicago’s Survey Lab containing a unique survey link. If you have not already completed the survey, please check your inbox and possibly your spam/junk mailbox for the email so that you can help us collect this important information. Please send any additional questions to nrg-broadcasts@nrgoncology.org.

REMINDER: Any manuscript or abstract resulting from research done under the auspices of our NCI grant awards must be processed through the NRG Publications Office before being submitted to the journal or association. Please remember to cite any pertinent grant numbers in these publications.


Please note the following upcoming meetings and abstract submission deadlines



UPCOMING MEETINGS

American Association for Thoracic Surgery (AATS); Apr 27-30, 2024; Toronto, ON


American Brachytherapy Society (ABS) World Congress; Jul 10-13, 2024; National Harbor, MD


American Head and Neck Society (AHNS); May 15-16, 2024; Chicago, IL


American Radium Society (ARS); May 2-5, 2024; Palm Springs, CA


American Society of Clinical Oncology (ASCO); May 31-Jun 4, 2024; Chicago, IL


American Society of Colon and Rectal Surgeons (ASCRS); Jun 1-4, 2024; Baltimore, MD


European Society for Medical Oncology (ESMO) Breast Cancer; May 15-17, 2024; Berlin, Germany


European Society for Medical Oncology (ESMO) Gastrointestinal; Jun 26-29, 2024; Munich, Germany


European Society for Medical Oncology (ESMO) Gynaecological; Jun 20-22, 2024; Florence, Italy


European Society for Radiotherapy and Oncology (ESTRO); May 3-7, 2024; Glasgow, Scotland


International Society for Quality-of-Life Research (ISOQOL); Oct 13-16, 2024; Cologne, Germany


Society for Clinical Trials (SCT); May 19-22, 2024; Boston, MA

Western Association of Gynecologic Oncologists (WAGO); Jun 12-15, 2024;

Seattle, WA


UPCOMING ABSTRACT SUBMISSION DEADLINES

American Society for Radiation Oncology (ASTRO); Sep 29-Oct 2, 2024; Washington, DC; LBA Jul 12, 2024


EORTC-NCI-AACR Symposium on Molecular Targets and therapies; Oct 23-25, 2024; Barcelona, Spain; due to publications committee Jun 13, 2024; submission deadline Jun 27, 2024; LBA Sep 26, 2024


European Society for Medical Oncology (ESMO); Sep 13-17, 2024; Barcelona, Spain; due to publications committee Apr 23, 2024; submission deadline May 7, 2024, 21:00 CET; LBA Aug 7, 2024, 21:00 CET (placeholder required)


International Gynecologic Cancer Society (IGCS); Oct 16-18, 2024; Dublin, Ireland; due to publications committee Apr 16, 2024; submission deadline Apr 30, 2024, 23:59 IST; LBA Jul 2, 2024, 23:59 IST


Radiological Society of North America (RSNA); Dec 1-5, 2024; Chicago, IL; due to publications committee Apr 17, 2024; submission deadline May 1; 2024


San Antonio Breast Cancer Society (SABCS); Dec 10-14, 2024; San Antonio, TX; due to publications committee Jun 26, 2024; submission deadline Jul 10, 2024, 11:59 pm CT; LBA Sep 30, 2024, 11:59 pm CT



Society for Immunotherapy of Cancer (SITC); Nov 6-10, 2024; Houston, TX; due to publications committee May 15, 2024; submission deadline Jun 27, 2024

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