Principal Investigator

Deborah Watkins
Bruner
Awardee Organization

Nrg Oncology Foundation, Inc.
United States

Fiscal Year
2024
Activity Code
UG1
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

NRG Oncology NCORP Research Base

The objective of this proposal is to establish and maintain the NCORP (National Community Oncology Research Program) for the NRG Oncology research base. The NRG NCORP is the result of aligning the legacy CCOPs (Community Clinical Oncology Programs) from three NCI Cancer Cooperative Groups: NSABP, RTOG and GOG. These groups together have over almost 100 years of combined experience serving as CCOP Research Bases. NRG NCORP, comprised of a multi-disciplinary team of investigators and patient advocates, is poised to carry out the objectives of: 1) designing and conducting cancer prevention, control and screening clinical trials; 2) designing and embedding patient reported outcomes in both primary NCOPR trials as well as NRG therapeutic trials 3) designing and conducting cancer care delivery research; 4) enhancing community access to treatment and imaging trials conducted under the National Clinical Trials Network (NCTN) and 5) conducting primary intervention trials and integrating health disparity research questions into cancer care delivery research and treatment trials. To allow NRG NCORP to meet these goals, the group will: participate fully in NRG Oncology leadership and will determine the scientific direction and prioritization of the NRG NCORP activities and resources and oversee the translational research, clinical trial activities, and correlative studies related to the aims of NRG NCORP. With the NRG Statistical and Data Management Center (SDMC), this team will provide efficient, methodologically up-to-date trial design with a focus on NCORP specific needs such as patient-reported repeated longitudinal assessments and cluster-randomized designs. NRG NCORP will provide study monitoring, reporting, and analysis; build an infrastructure to support our cancer care delivery research agenda; provide comprehensive data management quality control and quality assurance programs to ensure high data integrity and timely data for analysis; leverage cutting edge information technology emphasizing security, timeliness, and efficiency of data collection and management; providing RT credentialing and quality assurance; and provide education and training for institutional Clinical Research Associates, Study Chairs, local Principal Investigators and others involved in the NRG NCORP research agenda. Further, to accomplish these aims NRG NCORP will engage fully with NCI-designated NCORP community physicians and patient advocates as well as the NCI and other NCI-sponsored entities (cooperative groups, cancer centers, SPOREs) to collaborate across the NCTN to improve cancer prevention and control, cancer care and outcomes, and quality of life for patients affected by cancer.

Publications

  • Henry NL, Unger JM, Schott AF, Fehrenbacher L, Flynn PJ, Prow DM, Sharer CW, Burton GV, Kuzma CS, Moseley A, Lew DL, Fisch MJ, Moinpour CM, Hershman DL, Wade JL 3rd. Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Feb 1;36(4):326-332. Epub 2017 Nov 14. PMID: 29136387
  • McLouth LE, Nightingale CL, Dressler EV, Snavely AC, Hudson MF, Unger JM, Kazak AE, Lee SJC, Edward J, Carlos R, Kamen CS, Neuman HB, Weaver KE. Current Practices for Screening and Addressing Financial Hardship within the NCI Community Oncology Research Program. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2021 Apr;30(4):669-675. Epub 2020 Dec 21. PMID: 33355237
  • Nightingale CL, Sterba KR, McLouth LE, Kent EE, Dressler EV, Dest A, Snavely AC, Adonizio CS, Wojtowicz M, Neuman HB, Kazak AE, Carlos RC, Hudson MF, Unger JM, Kamen CS, Weaver KE. Caregiver engagement practices in National Cancer Institute Clinical Oncology Research Program settings: Implications for research to advance the field. Cancer. 2021 Feb 15;127(4):639-647. Epub 2020 Nov 2. PMID: 33136296
  • Albain KS, Gray RJ, Makower DF, Faghih A, Hayes DF, Geyer CE, Dees EC, Goetz MP, Olson JA, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Wood WC, Keane MM, Gomez HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW, Sparano JA. Race, Ethnicity, and Clinical Outcomes in Hormone Receptor-Positive, HER2-Negative, Node-Negative Breast Cancer in the Randomized TAILORx Trial. Journal of the National Cancer Institute. 2021 Apr 6;113(4):390-399. PMID: 32986828
  • Margolese RG, Cecchini RS, Julian TB, Ganz PA, Costantino JP, Vallow LA, Albain KS, Whitworth PW, Cianfrocca ME, Brufsky AM, Gross HM, Soori GS, Hopkins JO, Fehrenbacher L, Sturtz K, Wozniak TF, Seay TE, Mamounas EP, Wolmark N. Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial. Lancet (London, England). 2016 Feb 27;387(10021):849-56. Epub 2015 Dec 11. PMID: 26686957
  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, Geyer CE Jr, Dees EC, Goetz MP, Olson JA Jr, Lively T, Badve SS, Saphner TJ, Wagner LI, Whelan TJ, Ellis MJ, Paik S, Wood WC, Ravdin PM, Keane MM, Gomez Moreno HL, Reddy PS, Goggins TF, Mayer IA, Brufsky AM, Toppmeyer DL, Kaklamani VG, Berenberg JL, Abrams J, Sledge GW Jr. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. The New England journal of medicine. 2018 Jul 12;379(2):111-121. Epub 2018 Jun 3. PMID: 29860917
  • Wagner LI, Pugh SL, Small W Jr, Kirshner J, Sidhu K, Bury MJ, DeNittis AS, Alpert TE, Tran B, Bloom BF, Mai J, Yeh A, Sarma K, Becker M, James J, Bruner DW. Screening for depression in cancer patients receiving radiotherapy: Feasibility and identification of effective tools in the NRG Oncology RTOG 0841 trial. Cancer. 2017 Feb 1;123(3):485-493. Epub 2016 Nov 10. PMID: 27861753
  • Kircher S, Duan F, An N, Gareen IF, Sicks JD, Sadigh G, Suga JM, Kehn H, Mehan PT, Bajaj R, Hanson DS, Dalia SM, Acoba JD, Yasar DG, Park ER, Wagner LI, Carlos RC. Patient-Reported Financial Burden of Treatment for Colon or Rectal Cancer. JAMA network open. 2024 Jan 2;7(1):e2350844. PMID: 38194233
  • Azim HA Jr, Niman SM, Partridge AH, Demeestere I, Ruggeri M, Colleoni M, Saura C, Shimizu C, Saetersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Ruíz-Borrego M, Moore HCF, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Klar NJ, Spanic T, Ruddy K, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O, Peccatori FA. Fertility Preservation and Assisted Reproduction in Patients With Breast Cancer Interrupting Adjuvant Endocrine Therapy to Attempt Pregnancy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2024 Aug 10;42(23):2822-2832. Epub 2024 May 29. PMID: 38810178
  • Brown JC, Ma C, Shi Q, Zemla T, Couture F, Kuebler P, Kumar P, Tan B, Krishnamurthi S, Chang V, Goldberg RM, Venook AP, Blanke CD, O'Reilly EM, Shields AF, Meyerhardt JA. Physical activity in recurrent colon cancer: Cancer and Leukemia Group B/SWOG 80702 (Alliance). Cancer. 2023 Dec 1;129(23):3724-3734. Epub 2023 Aug 31. PMID: 37651160
  • Wagner LI, Gray RJ, Sparano JA, Whelan TJ, Garcia SF, Yanez B, Tevaarwerk AJ, Carlos RC, Albain KS, Olson JA Jr, Goetz MP, Pritchard KI, Hayes DF, Geyer CE, Dees EC, McCaskill-Stevens WJ, Minasian LM, Sledge GW Jr, Cella D. Patient-Reported Cognitive Impairment Among Women With Early Breast Cancer Randomly Assigned to Endocrine Therapy Alone Versus Chemoendocrine Therapy: Results From TAILORx. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2020 Jun 10;38(17):1875-1886. Epub 2020 Apr 9. PMID: 32271671
  • McLouth LE, Zheng Y, Smith S, Hodi FS, Rao UN, Cohen GI, Amatruda TT, Dakhil SR, Curti BD, Nakhoul I, Chandana SR, Bane CL, Marinier DE, Lee SJ, Sondak VK, Kirkwood JM, Tarhini AA, Wagner LI. Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2023 Jan;32(1):183-196. Epub 2022 Aug 27. PMID: 36029412
  • Brown JC, Ma C, Shi Q, Couture F, Kuebler P, Kumar P, Tan B, Krishnamurthi S, Chang V, Goldberg RM, O'Reilly EM, Shields AF, Meyerhardt JA. Inflammation, Physical Activity, and Disease-Free Survival in Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance). Journal of the National Cancer Institute. 2024 Aug 24. Epub 2024 Aug 24. PMID: 39180477
  • Penney KL, Banbury BL, Bien S, Harrison TA, Hua X, Phipps AI, Sun W, Song M, Joshi AD, Alberts SR, Allegra CJ, Atkins J, Colangelo LH, George TJ, Goldberg RM, Lucas PC, Nair SG, Shi Q, Sinicrope FA, Wolmark N, Yothers G, Peters U, Newcomb PA, Chan AT. Genetic Variant Associated With Survival of Patients With Stage II-III Colon Cancer. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association. 2020 Nov;18(12):2717-2723.e3. Epub 2019 Dec 4. PMID: 31811950
  • Partridge AH, Niman SM, Ruggeri M, Peccatori FA, Azim HA Jr, Colleoni M, Saura C, Shimizu C, Sætersdal AB, Kroep JR, Mailliez A, Warner E, Borges VF, Amant F, Gombos A, Kataoka A, Rousset-Jablonski C, Borstnar S, Takei J, Lee JE, Walshe JM, Ruíz-Borrego M, Moore HCF, Saunders C, Bjelic-Radisic V, Susnjar S, Cardoso F, Smith KL, Ferreiro T, Ribi K, Ruddy K, Kammler R, El-Abed S, Viale G, Piccart M, Korde LA, Goldhirsch A, Gelber RD, Pagani O, International Breast Cancer Study Group, POSITIVE Trial Collaborators, Azim HA Jr, Peccatori F, Ribi K, Abi-Khattar C, Amant F, Barbro Sætersdal A, Bjelic-Radisic V, Blacher L, Borges V, Borrego MR, Borstnar S, Cardoso F, Colleoni M, Demeestere I, Di Leo A, Eon Lee J, Ferreiro T, Gelber R, Gelmon K, Hiltbrunner A, El-Abed S, Ignatiadis M, Jani P, Kammler R, Walshe JM, Kroep J, Loi S, Mailliez A, Mavroudis D, Moore H, Naughton M, Niman SM, Paluch-Shimon S, Rabaglio M, Regan MM, Roschitzki H, Ruddy K, Ruepp B, Ruggeri M, Saunders C, Saura C, Shaw H, Shimizu C, Smith KL, Spanic T, Susnjar S, Symmans F, Viale G, Boyle F, Jerusalem G, Stahel R, Aebi S, Baas P, McGregor K, Peters S, Popat S, Rosell R, Achille G, Adam S, Alleman S, Campus I, Carrer-Wagner A, Celotto D, Comune C, Fournarakou M, Frapolli M, Gasca A, Giacomelli N, Hahn B, Karagol R, Keglowich L, Maddox C, Maibach R, Marbot M, Mathys M, Pardo Contreras M, Nesa M, Nobs L, Pfister R, Roux S, Rugiati E, Sanchez-Hohl M, Schneider M, Schroeder J, Sicher P, Troesch S, Wagner M, Weber M, Wenger M, Wiedemann M, Wyss F, Zenklusen I, Zigomo I, Züger D, Bouzan C, Cole B, Gelber S, Huang H, Mahoney C, Northrop L, Sun Z, Blackwell M, Harrison D, Fischer S, Kassab G, Mundy L, Narayanan D, Palermo V, Polizzi D, Scott K, Starkweather R, Swick-Jemison J, Veira Y, Weinbaum D, Bernhard J, Andrighetto S, Ciocca F, Dell'Orto P, Russo L, Benini E, Arrigoni L, Schina I, Dechene J, Rothé F, Maetens M, Goldhirsch A, Korde L, Piccart M, Schmitz S, El-Abed S, De Swert H, Jooris M, Leemans J, Questiaux G, Beaupère L, Straehle C, Mooney M, Colleoni M, Artioli F, Cretella E, Gallerani E, Sanna G, Chini C, Ferro A, Spazzapan S, Seles E, De Giorgi U, Tausch C, Rossi L, Rabaglio M, Zaman K, Vetter M, Dedes K, Bodmer A, Leo C, Riniker S, Borner M, Membrez V, Amant F, Gombos A, Jerusalem G, Quaghebeur C, Borstnar S, El Saghir NS, Saura C, Iranzo V, Perelló A, Luna Barrera AM, González X, Cardoso F, Guerra J, Sanchez Henarejos P, Virizuela JA, López R, Andrés R, Kataoka A, Takei J, Nakamura S, Shien T, Tugawa K, Bando H, Kawashima M, Tokunaga E, Tada H, Kawano J, Masuda N, Yoshida M, Takahashi M, Tamura K, Egawa C, Shimuzu C, Partridge AH, Dilawari AA, Flaum E, McAndrew PF, Casteel CM, Smith KL, Al Baghdadi T, Cigler T, Sparano JA, DiBella N, Masters GA, Anderson DM, Reeder-Hayes KE, Crawford J, Radford JE, Schwartz GN, Ruiz Dayao Z, Beck AC, William IJ, Warner E, Gelmon KA, Webster M, Haq R, Elser C, Pavic M, Desbiens C, Barbro Sætersdal A, Kroep JR, Mailliez A, Rousset-Jablonski C, Debled M, Borges VF, Sanft TB, Yung RL, Ángel García-Sáenz J, Ruiz-Borrego M, José Bermejo Pérez M, Illarramendi JJ, Del Barco S, Walshe JM, Korpanty G, Keane M, Kennedy J, Saunders C, Bjelic-Radisic V, Greil R, Czech T, Lee JE, Jeong Kim H, Susnjar S, Ballinger TJ, Wapnir IL, Borges VF, Meisel JL, Steen PD, Mavroudis D, Kaufman B, Vici P. Interrupting Endocrine Therapy to Attempt Pregnancy after Breast Cancer. The New England journal of medicine. 2023 May 4;388(18):1645-1656. PMID: 37133584
  • Atherton PJ, Watkins-Bruner DW, Gotay C, Moinpour CM, Satele DV, Winter KA, Schaefer PL, Movsas B, Sloan JA. The Complementary Nature of Patient-Reported Outcomes and Adverse Event Reporting in Cooperative Group Oncology Clinical Trials: A Pooled Analysis (NCCTG N0591). Journal of pain and symptom management. 2015 Oct;50(4):470-9.e9. Epub 2015 May 30. PMID: 26031708
  • Basch E, Dueck AC, Rogak LJ, Mitchell SA, Minasian LM, Denicoff AM, Wind JK, Shaw MC, Heon N, Shi Q, Ginos B, Nelson GD, Meyers JP, Chang GJ, Mamon HJ, Weiser MR, Kolevska T, Reeve BB, Bruner DW, Schrag D. Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Sep 11;36(31):JCO2018788620. Epub 2018 Sep 11. PMID: 30204536

Clinical Trials

Study Name Clinical Trial ID
Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases NCT02360215
Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Limited Stage or Extensive Stage Small Cell Lung Cancer NCT02635009
Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer NCT01649089
CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells NCT00892866
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability NCT04804644
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer NCT05646316
Survivorship Care Planning for Prostate Cancer Survivors NCT03860961
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer NCT04251052
Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer NCT03180294
Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors NCT05896189
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer NCT06532279