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Research and Scholarly Activity

Clinical Trials & Research

Clinicians and academic researchers in the Sentara Cancer Network partner with Virginia Oncology Associates, Eastern Virginia Medical School, George Mason University and other national and local healthcare organizations to conduct research that elevates patient care.  We offer research throughout the Sentara system, with a focus in Hampton Roads and Blue Ridge regions.

We are a proud and productive member in good standing of The Alliance for Clinical Trials for Oncology, funded by the National Cancer Institute. As a leading contributor to national research, we are committed to participating in promising clinical trials that make new first-line therapies available to patients right now. Our team also participates in research that may lead to better options for prevention, diagnosis and treatment in the future. One constant goal is to improve our patients’ quality of life.  These studies below represent a sample of our diverse research activities

Sentara Cancer Network Clinical Trial Accruals

Breast Cancer Research

A clinical trial (National Cancer Institute Trial “Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive Breast Cancer Treated With Chemotherapy” A011202) is underway at Sentara hospitals in Hampton Roads and at Sentara Martha Jefferson Hospital to determine whether women with node-positive breast cancer can forego axillary lymph node dissection during surgery and receive only radiation. This conservative approach would reduce the occurrence of painful lymphedema and help patients return to daily activities faster.

Women with ductal carcinoma in situ (DCIS), a noninvasive breast cancer, typically get some form of treatment, such as a lumpectomy or radiation. The Comparison of Operative to Monitoring and Endocrine Therapy (COMET) trial is testing an active surveillance approach similar to what doctors use to closely monitor prostate cancer in men. Breast specialists aggressively watch for signs of change, initiating treatment only when absolutely necessary.  This study is currently offered in Hampton Roads.

At Sentara Rockingham Medical Hospital, Dr. Heather Morgan wrote a Phase III Randomized protocol to Compare Miaderm with Mometasone alone plus Best Supportive Care to  Prevent Radiation Dermatitis in Patients Undergoing Breast Irradiation.  The purpose of this research study is to determine if a skincare cream provides additional benefit to the use of Mometasone in preventing the skin reaction caused by radiation therapy.  This study opened to enrollment in March 2017 and has an enrollment of 95 patients to date.

Lung Cancer Research

We are enrolling patients with non-small cell lung cancer into the Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST). The study looks for genetic markers for epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements to help determine if a patient will benefit from targeted therapy. If patients are identified with these mutations, they continue on to a treatment study focused on targeted therapy directed at treating that specific mutation.

Head and Neck Cancer Research

We are enrolling patients into an NCI funded clinical trial for locoregionally advanced head and neck cancer patients who have a contraindication to Cisplatin.  The patients are randomized to either radiotherapy with concurrent Durvalumab or concurrent Cetuximab, in an effort to establish a chemotherapy regimen with fewer side effects.  This study is enrolling at Sentara Norfolk General Hospital.

Basic Science Research

We are collaborating on several projects with George Mason University.  Most recently, we have provided biospecimens from consented patients who are identified with suspicious mammograms who need a biopsy.  GMU is using special mass spectrometry and nanotechnology to identify new, unique biomarkers in hopes to develop a test to be used in conjunction with mammography to improve the accuracy of detecting breast cancer.

We have partnered with Lifenet and the Institute for Regenerative Medicine to provide them tumor samples so they can test new methods for growing tumors in a lab.  The goal is to be able to quickly grow microtumors from these samples, test multiple chemotherapy options and potentially provide better patient directed therapy guidance to physicians.

We also continue to provide biospecimens to the Eastern Virginia Medical School biorepository for current and future research in cancer testing. 

2019 Oncology Publications

Gadgeel, SM., Lukas, RV, Goldschmidt, J., Conkling, P., et al.  Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases:  Exploratory analyses of the phase III OAK study.  Lung Cancer 2019 Feb; 128: 105-112. 

Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, et al.  Extended dosing with CC-486 (oral azacitidine) in patients with myeloid malignancies.  Am J Hematol. 2018 Oct: 93(10):  1199-1206  

Savona MR, Kolibaba K, Conkling P, et al. Phase I study of PSMA ADC, an antibody-drug conjugate targeting prostate-specific membrane antigen, in chemotherapy-refractory prostate cancer.  Prostate 2019 Jan. (Epub ahead of print)

Petrylak DP, Kantoff P, Vogelzang NJ, Mega A, Fleming MT, et al. Phase I Study of Seviteronel, a Selective CYP17 Lyase and Androgen Receptor Inhibitor, in Men with Castration-Resistant Prostate Cancer.  Clinical Cancer Research; 2018 Nov; 24(21): 5225-5232. 

Kim, S., Plemmons, J., Hoang, K., Chaudhuri, D., Kelley, A., Cunningham, T., Hoefer, R.  (2019).  Breast-Specific Gamma Imaging versus MRI: Comparing the diagnostic performance in assessing treatment response after neoadjuvant chemotherapy in patients with breast cancer.  American Journal of Roentgenology, 212 (3), 696-705.  DOI: 10.2214/AJR.17.18930

Matt D. Galsky, Sumanta K. Pal, Amir Mortazavi, Matthew I. Milowsky, Saby George, Sumati Gupta, Mark T. Fleming, et al.  Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients (pts) with metastatic urothelial cancer (mUC): HCRN GU14-182. Journal of Clinical Oncology 2019 37:15_suppl, 4504-4504 

Yohann, L., Necchi, A., Park, S.H., Garcia-Donas, J., Huddard, R., Burgess, E., Flemming, M., et al. (2019).  Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.  New England Journal of Medicine, 381(4), 338-348. 

O’Shaughnessy, J., Wright, G.S., Thummala, A.R., Danso, M., Et al.  (2019) Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncology, 20(11), 1587-1601 doi: 10.1016/S1470-2045(19)30616-3

J Vasc Interv Radiol. 2019 Jan;30(1):19-22. doi: 10.1016/j.jvir.2018.06.023. Epub 2018 Dec 6. Pilot Study Comparing Systemic and Tissue Pharmacokinetics of Irinotecan and Metabolites after Hepatic Drug-Eluting Chemoembolization. Levy EB1, Peer C2, Sissung TM2, Venkatesan A3, Pandalai P4, Greten T2, Hughes MS5, Garcia C6, Peretti J6, Figg W2, Lewis A7, Wood B6.

Utility of Radiation After Neoadjuvant Chemotherapy for Surgically Resectable Esophageal Cancer. Macedo FI, Mesquita-Neto JW, Kelly KN, Azab B, Yakoub D, Merchant NB, Livingstone AS, Franceschi D. Ann Surg Oncol. 2019 Dec 1. doi: 10.1245/s10434-019-07788-9. [Epub ahead of print]

The Role of Completion Lymphadenectomy in Positive Regional Lymph Nodes in Melanoma: A Meta-analysis. Macedo FI, Fayne RA, Azab B, Yakoub D, Möller MG. J Surg Res. 2019 Apr;236:83-91. doi: 10.1016/j.jss.2018.11.015. Epub 2018 Dec 7.

A large national comparative study of clinicopathological features and long-term survivals between esophageal gastrointestinal stromal tumor and leiomyosarcoma. Azab B, Macedo FI, Cass SH, Ripat C, Razi SS, Picado O, Franceschi D, Livingstone AS, Yakoub D. Am J Surg. 2019 Aug;218(2):323-328. doi: 10.1016/j.amjsurg.2018.10.046. Epub 2018 Nov 16.

Impact of Chemoradiation-to-Surgery Interval on Pathological Complete Response and Short- and Long-Term Overall Survival in Esophageal Cancer Patients. Azab B, Amundson JR, Picado O, Ripat C, Macedo FI, Franceschi D, Livingstone AS, Yakoub D. Ann Surg Oncol. 2019 Mar;26(3):861-868. doi: 10.1245/s10434-018-6897-4. Epub 2018 Oct 11.

2019 Oncology Presentations

LD Rodriguez, MS Baker, DW Karakla, DC Lieb. Primary lung adenocarcinoma in a sea of metastatic thyroid cancer. American Association of Clinical Endocrinologists 28th Annual Scientific and Clinical Congress, Los Angeles, CA, April 24-29, 2019.

Richard Hoefer, DO – Presentation at ACS Quality and Safety Meeting in June, 2019 on DEVELOPING A PANCREAS CONSORTIUM: A PLATFORM TO PROMOTE MULTIDISCIPLINARY CARE, BEST PRACTICES, AND MONITOR QUALITY METRICS ACROSS MULTIPLE DIVERSE HOSPITALS WITHIN A SINGLE LARGE HEALTH SYSTEM

Richard Hoefer, DO – Presentation at George Mason University on REFLECTIONS OF A SURGICAL ONCOLOGIST:“THE ROAD TO ACHIEVING ONE’S DREAM IS NEVER A STRAIGHT LINE”. June 2019

Richard Hoefer, DO – Presentation to the Komen Foundation Survivorship Day at the Jefferson Hotel, Richmond VA 4 October 2019: “HISTORY OF BREAST CANCER SURGERY”

ASCO
Randomized double-blind phase II study of maintenance pembrolizumab versus placebo after first-line chemotherapy in patients with metastatic urothelial cancer: HCRN GU14-182.  It was presented at the 2019 ASCO Annual Meeting on 6/3/2019.  Dr. Fleming is an author.

ESMO Congress Barcelona 2019