May 1, 2023

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WEEKLY HIGHLIGHT

The NRG Oncology 2023 Summer Meeting is now open for registration!

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Summer Meeting Registration is Open!

The NRG Oncology 2023 Summer Meeting is now open for registration! The Meeting will be held in Philadelphia from Thursday, July 20, 2023 - Saturday, July 22, 2023. Sessions will be held in-person and available via streaming unless noted. Additionally, there will be virtual-only sessions on Monday and Tuesday, July 17-18, 2023.



Click here to Register Today

AMENDMENTS

GENITOURINARY

NRG-GU011: Amendment 2; March 23, 2023, posted on CTSU.


CLOSURES

GASTROINTESTINAL

NRG-GI007: Temporary Closure Notice: April 21, 2023 (posted on CTSU). The trial is temporarily closed to accrual for a protocol-specified toxicity analysis.


OTHER PROTOCOL NOTICES

1. ALL DISEASE SITES

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


2. CANCER PREVENTION & CONTROL

NRG-CC005/FORTE: Join the next FORTE site call on May 17 at 4pm EDT, an informal discussion on study progress and conduct with the NRG FORTE team, featuring Kaiser Permanente representatives to share about their screening and enrolling processRegister today at this link!


3. GASTROINTESTINAL

NRG-GI004/SWOG S1610 (COMMIT): Amendment 9 Overview webinars are being held on May 16 at 10am EDT and 4pm EDT. Please see the memorandum (posted on CTSU) for details and how to register for one of the sessions.

 

NRG-GI008/CIRCULATE-US: Please see the memorandum dated May 1, 2023 (posted on CTSU) re: the capecitabine dosing schedule for this protocol.

 

NRG-GI005 (COBRA) / NRG-GI008 (CIRCULATE-US): The webinar “Surgical implications of ctDNA: Is this the future for colon cancer?” is being held on May 4. Please visit the NRG Oncology website or see the memorandum (posted on CTSU) for details and how to register for the session.

 

4. GENITOURINARY

NRG-GU009 and NRG-GU010:

Reminder: DECIPHER SPECIMEN- Block or Slides must be from the highest tumor grade (Gleason score) Without the Decipher testing on the highest Gleason specimen, the patient wouldn’t be eligible for enrollment into the study.

 

NRG-GU011: Physician referral letter is posted on CTSU.

 

5. 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 cancer.

 

NRG-GY012 and NRG-GY023 – Reminder: BLOOD PRESSURE CUFF SUPPLY IS VERY LIMITED - Please be advised that VWR has a very limited supply of blood pressure cuffs at present. Please check your supplies on site for any overlooked cuffs prior to ordering. Thank you for your cooperation. 

 

Printing Biospecimen Transmittal PDFs on GYN Trials

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

 

6. HEAD AND NECK

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

study with the overall goal of improving the outcome and/or quality of life for patients with endometrial


7. 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, NRG-CC005, and NRG/SWOG S1914. Space is limited so register now and reserve your seat. The next webinar training is scheduled for Wednesday, May 3, 2023.

DRUG SAFETY AND INVESTIGATOR'S BROCHURE (IB) UPDATES

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

DRUG NAME

PROTOCOL

WEBSITE FOR

SAFETY REPORTS

INVESTIGATOR'S

BROCHURE (IB)*

Apalutamide

NRG-GU006

NRG-GU008

NRG-GU009



X

X

X

Cediranib

NRG-GY004

NRG-GY005

NRG-GY012

NRG-GY023


CTSU

CTSU

CTSU

CTSU


Durvalumab

NRG-GY012

NRG-GY023

CTSU

CTSU


Ipilimumab

NRG-BN007

NRG-GY025



X

X

Nivolumab

NRG-BN002

NRG-BN007

NRG-GU012

NRG-GY025

NRG-HN005

NRG-HN007

NRG-LU002


NRG

CTSU

CTSU

NRG

CTSU

CTSU

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. 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).

1. Call for Applications for NRG Committee Leadership position

Vice Chair, Cancer Control Committee

Application Deadline: May 26, 2023

We are seeking nominations for the position of Vice-Chair of the NRG NCORP Cancer Control committee. The successful candidate will work closely with Dr. Lisa Kachnic in continuing to lead the Cancer Control committee. Candidates for this position should have an active program of funded research and publications focused on the NRG cancer control priorities of improvement or delay in decline of neurocognitive function, reducing gender specific symptoms such as lymphedema and sexual function, and testing therapeutic delivery modifications to improve QoL and cost-effectiveness in localized cancers while maintaining efficacy. Candidates should have a track record of mentorship and a willingness to provide timely consultation to members and liaisons of NRG committees as concepts and protocols are being developed. Click here for more information.


2. Cisplatin and Carboplatin Drug Shortages

There is currently a shortage of cisplatin nationwide. Please review this memo for a list of NRG studies that involve the use of commercial Cisplatin and/or Carboplatin, and the recommended strategies for enrolling participants in NRG trials involving Cisplatin and/or Carboplatin.

 

3. NRG Oncology Study Results Confirm Conventional External Beam Radiotherapy Should Remain Standard of Care in Treating Localized Vertebral Metastases of the Spine

Results from the NRG Oncology RTOG 0631 clinical trial comparing stereotactic vs. conventional radiotherapy for localized vertebral metastases of the spine did not meet its primary endpoint. Data from the study suggests that radiosurgery was not considered superior in terms of pain responses at 3 months following treatment, and even displayed worse pain response, than the conventional external beam radiotherapy (cEBRT). These results were recently published in the JAMA Oncology. Read the press release


4. NRG Oncology Trial Does Not Improve Overall Survival, but Shows Improvements in Several Clinical Outcomes for Men with Intermediate-Risk Prostate Cancer

Results from the phase 3 NRG Oncology RTOG 0815 clinical study comparing dose-escalated radiotherapy (RT) alone to dose-escalated RT with short-term androgen deprivation (STAD) did not meet its primary endpoint of improving overall survival for men with intermediate-risk prostate cancer through the addition of STAD. Although this study did not meet its primary aim, the addition of STAD to dose-escalated RT was associated with improvements in rates of biochemical failure, distant metastases, and prostate cancer-specific mortality. These results were recently published in the Journal of Clinical Oncology. Read the press release


5. Patient-Reported Outcomes from an NRG Oncology Study of Androgen Deprivation Therapy with Dose-Escalated Radiotherapy for Intermediate-Risk Prostate Cancer Show No Clinically Meaningful Differences in Scores at One Year Post-Treatment

The patient-reported outcomes (PROs) of the phase 3 NRG Oncology clinical trial RTOG 0815 comparing dose-escalated radiotherapy (RT) alone to dose-escalated RT combined with short-term (6 months) androgen deprivation therapy (STAD) indicate that the addition of STAD did not significantly impact urinary or bowel quality of life but did significantly decrease hormone and sexual quality of life. However, this decline in quality of life was temporary and there were no clinically meaningful differences in quality of life between treatment arms by one year after the initiation of treatment. These results were recently published in the Journal of Clinical Oncology. Read the press release


6. NRG Mentorship Working Group Update

Are you a new CRA or CTN within NRG Oncology? Would you like a mentor to help guide you through your new role as a CRA or CTN? Are you an institution in need of more guidance after an audit? The Mentorship Working Group can provide you a mentor! You can apply for a mentor by going to the Introductory Materials page on the NRG website. You will find the Mentor Form to complete. The instructions on how to submit are located on the form. Hope to hear from you soon!

 

7. Presentation Slides & Virtual Backgrounds

NRG presentation slides and virtual backgrounds have moved on our website! Check them out at https://www.nrgoncology.org/Clinical-Trials/Publications/Presentation-Slides-and-Backgrounds

 

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

Ryu S, Deshmukh S, Timmerman RD, Movsas B, Gerszten P, Yin FF, Dicker A, Abraham CD, Zhong J, Shiao SL, Tuli R, Desai A, Mell LK, Iyengar P, Hitchcock YJ, Allen AM, Burton S, Brown D, Sharp HJ, Dunlap NE, Siddiqui MS, Chen TH, Pugh SL, Kachnic LA. Stereotactic Radiosurgery vs Conventional Radiotherapy for Localized Vertebral Metastases of the Spine: Phase 3 Results of NRG Oncology/RTOG 0631 Randomized Clinical Trial. JAMA Oncol. 2023 Apr 20:e230356. doi: 10.1001/jamaoncol.2023.0356. Epub ahead of print. PMID: 37079324; PMCID: PMC10119775. Read more.

 

Hallemeier CL, Moughan J, Haddock MG, Herskovic AM, Minsky BD, Suntharalingam M, Zeitzer KL, Garg MK, Greenwald BD, Komaki RU, Puckett LL, Kim H, Lloyd S, Bush DA, Kim HE, Lad TE, Meyer JE, Okawara GS, Raben A, Schefter TE, Barker JL Jr, Falkson CI, Videtic GMM, Jacob R, Winter KA, Crane CH. Association of Radiotherapy Duration With Clinical Outcomes in Patients With Esophageal Cancer Treated in NRG Oncology Trials: A Secondary Analysis of NRG Oncology Randomized Clinical Trials. JAMA Netw Open. 2023 Apr 3;6(4):e238504. doi: 10.1001/jamanetworkopen.2023.8504. PMID: 37083668; PMCID: PMC10122174. Read more.

 

Krauss DJ, Karrison T, Martinez AA, Morton G, Yan D, Bruner DW, Movsas B, Elshaikh M, Citrin D, Hershatter B, Michalski JM, Efstathiou JA, Currey A, Kavadi VS, Cury FL, Lock M, Raben A, Seaward SA, El-Gayed A, Rodgers JP, Sandler HM. Dose-Escalated Radiotherapy Alone or in Combination With Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer: Results of a Phase III Multi-Institutional Trial. J Clin Oncol. 2023 Apr 27:JCO2202390. doi: 10.1200/JCO.22.02390. Epub ahead of print. PMID: 37104748. Read me.

 

Movsas B, Rodgers JP, Elshaikh MA, Martinez AA, Morton GC, Krauss DJ, Yan D, Citrin DE, Hershatter BW, Michalski JM, Ellis RJ, Kavadi VS, Gore EM, Gustafson GS, Schulz CA, Velker VM, Olson AC, Cury FL, Papagikos MA, Karrison TG, Sandler HM, Bruner DW. Dose-Escalated Radiation Alone or in Combination With Short-Term Total Androgen Suppression for Intermediate-Risk Prostate Cancer: Patient-Reported Outcomes From NRG/Radiation Therapy Oncology Group 0815 Randomized Trial. J Clin Oncol. 2023 Apr 27:JCO2202389. doi: 10.1200/JCO.22.02389. Epub ahead of print. PMID: 37104723. Read more.

 

Please note the following upcoming meeting and abstract submission deadlines


UPCOMING MEETINGS

American Association for Thoracic Surgery (AATS); May 6-9, 2023; Los Angeles, CA


American College of Radiology (ACR); May 6-10, 2023; Washington, DC


American Society of Clinical Oncology (ASCO); Jun 2-6, 2023; Chicago, IL


ESMO Breast Cancer Annual Congress; May 11-13, 2023; Berlin, Germany


European Society for Radiotherapy and Oncology (ESTRO); May 12-16, 2023; Vienna, Austria


Society for Clinical Trials (SCT); May 21-24, 2023; Baltimore, MD


Western Association of Gynecologic Oncologists (WAGO); Jun 14-17, 2023; Monterey, CA


UPCOMING ABSTRACT SUBMISSION DEADLINES

American Society for Radiation Oncology (ASTRO); Oct 1-4, 2023; Chicago, IL; LBA Jul 12, 2023


ESMO World Congress on Gastrointestinal Cancer; Jun 28-Jul 1, 2023; Barcelona, Spain; LBA Jun 15, 2023


European Society of Gynaecological Oncology (ESGO); Sep 28-Oct 1, 2023; Istanbul, Turkey; meeting submission deadline May 8, 2023; LBA Aug 7, 2023


European Society for Medical Oncology (ESMO) Congress; Oct 20-24, 2023; Madrid, Spain; meeting submission deadline May 10, 2023, 9pm CntEurSummerTime (CEST); LBA Sep 14, 2023, 9pm CEST


International Gynecologic Cancer Society (IGCS); Nov 5-7, 2023; Seoul, South Korea; meeting submission deadline May 8, 2023, Abstract & Film; TiP LBA, Aug 21, 2023


International Society for Quality-of-Life Research (ISOQOL); Oct 18-21, 2023; Calgary, AB Canada; LBA Jul 7, 2023


Radiological Society of North America (RSNA); Nov 27-Dec 1, 2023; Chicago, IL; meeting submission deadline; May 3, 2023, 12 Noon CT

 

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