NCORP Grant Submission Creates New Opportunities for Community Involvement and Cancer Care Delivery Research  

In early January 2014, leaders of ECOG-ACRIN's Cancer Control and Outcomes Program spearheaded the submission of a grant application to the National Cancer Institute (NCI) to fund the group as a Research Base in the NCI National Community Oncology Research Program, known familiarly as NCORP. Lynne I. Wagner, PhD, (Northwestern University), ECOG-ACRIN's Deputy Chair of Cancer Control and Outcomes, and Mitchell D. Schnall, MD, PhD (University of Pennsylvania), ECOG-ACRIN's Group Co-Chair, are the principal investigators for the grant, which was prepared by a writing team of over 30 scientific committee leaders and staff. 

The NCORP application proposes a wide array of multidisciplinary community-based research that will, at once, carry on ECOG-ACRIN's seminal research in cancer control and patient-centered outcomes, and break new ground in the area of cancer care delivery research. The application proposes a number of innovative collaborations with NCORP and external stakeholders that, if funded, will expand ECOG-ACRIN's existing research capabilities. 

Watch for more stories about the NCORP grant in upcoming newsletters.  
ECOG-ACRIN Adopts New Protocol Identification System   

As part of its consolidation of adult cooperative groups, the National Cancer Institute (NCI) asked each merged group to propose a protocol identification (ID) system to ensure that future studies will be easily associated with the new group. The ECOG-ACRIN Cancer Research Group recently developed a protocol ID system, which was approved by the NCI. With a few exceptions, all ECOG-ACRIN protocols approved by NCI after October 1, 2013 will be identified with the new system. All trials approved prior to that time will retain their legacy ID.

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Breast Cancer Committee Transitions to New Leadership
Kathy D. Miller, MD (Indiana University) began her new position as Chair of the ECOG-ACRIN Breast Committee on January 1, 2014, after serving as Co-Chair since 2011. Dr. Miller succeeds Joseph A. Sparano, MD (Albert Einstein College of Medicine), who after serving as Co-Chair and Chair of the Breast Committee since 2002 became Vice Chair of ECOG-ACRIN last year. She leads the Committee along with Imaging Chair Christopher E. Comstock, MD (Memorial Sloan-Kettering Cancer Center) and Antonio C. Wolff, MD (Johns Hopkins University), who is replacing Dr. Miller as Co-Chair of the Committee.
Kathy D.
Miller, MD
Christopher E. Comstock, MD
Antonio C. 
Wolff, MD


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Dr. Benson Reflects on a Generation of GI Oncology Research  

In November 2013, after 24 years of leadership service to the Gastrointestinal (GI) Committee, Al B. Benson III, MD, FACP, FASCO (Northwestern University), stepped down as its chair, handing over the leadership to Peter O'Dwyer, MD (University of Pennsylvania). Dr. Benson was appointed Co-Chair of the GI Committee in 1989 and named its Chair in 1991. During his tenure, the GI Committee became a major national force in GI cancer research. Among its many accomplishments, the GI Committee led E5202 and E4203, two of the first biomarker-driven trials ever to be performed in the cooperative group system in colorectal cancer. 

E5202, the first national trial to include stratification to observation vs. randomization, used a real-time assay of microsatellite instability/18q loss of heterozygosity status for treatment selection in 3000 patients with stage II colon cancer. The trial established the cooperative groups' ability to perform large-scale trials on a national level, wherein risk stratification was accomplished through rapid, clinically acceptable laboratory turnaround times. E4203, a trial for patients with advanced colorectal cancer, assigned patients to treatment on the basis of thymidylate synthase expression. 


Read Dr. Benson's authored article "Reflections on Two Decades of GI Cancer Research."


Young Investigators Present Research at Fall Group Meeting

The 13th annual ECOG-ACRIN Young Investigator Symposium took place at the Fall 2013 Group Meeting at the Westin Diplomat Resort & Spa in Hollywood, FL. The symposium, a professional mentoring event, recognizes promising young translational scientists and clinical investigators and exposes them to cooperative group research opportunities early in their careers.
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FDA Filing for New Breast and Leukemia Trials

The ECOG-ACRIN Cancer Research Group is currently working in concert with the National Cancer Institute, Food and Drug Administration, and pharmaceutical companies on three randomized phase III trials designed for regulatory drug approval. The Breast Committee is investigating entinostat in metastatic breast cancer in E2112 (N=600 patients), which will open soon to patient enrollment. Entinostat is manufactured by Syndax. E2112 is the first phase III trial of epigenetic therapy in metastatic disease. The lead investigator for E2112 is Roisin Connolly, MB, BCh (Johns Hopkins University), a young investigator under the mentorship of Kathy D. Miller, MD (Indiana University), who chairs the Breast Committee. 

The Leukemia Committee is investigating ibrutinib, a small molecule inhibitor of Bruton's tyrosine kinase, in combination with rituximab in E1912 (N=519 patients), which is currently open to patient enrollment. E1912 will evaluate the ability of the ibrutinib-based therapy to prolong progression-free survival in patients with chronic lymphocytic leukemia, or CLL. Tait D. Shanafelt, MD (Mayo Clinic), a young investigator, is leading E1912 under the mentorship of Neil E. Kay, MD (Mayo Clinic). Ibrutinib is manufactured by Pharmacyclics.

The Leukemia Committee is also investigating blinatumomab, the first BiTEŽ antibody to be developed for the treatment of cancer, in E1910 (N=360 patients), also open to patient enrollment at this time. Blinatumomab is manufactured by Amgen. E1910 will compare overall survival after treatment with blinatumomab in combination with chemotherapy vs. chemotherapy alone in newly diagnosed patients with BCR-ACL-negative B-lineage acute lymphoblastic leukemia, or ALL. Mark R. Litzow, MD (Mayo Clinic) is the lead investigator for E1910. Ryan J. Mattison, MD (University of Wisconsin) is a young investigator co-leading the study under the mentorship of Dr. Litzow. Dr. Litzow also chairs the Leukemia Committee.

These trials are being conducted by ECOG-ACRIN under the sponsorship of the NCI. Patient recruitment will involve participation from SWOG, the Alliance for Clinical Trials in Oncology, and NRG Oncology, the three other network groups of the NCI National Clinical Trials Network that conduct cancer research in adults, like ECOG-ACRIN.


View the E1910 press release...

View the E1912 press release...

14 New Trials Activated Since Mid 2013
Protocol development activity was robust in recent months across the three ECOG-ACRIN scientific programs--Cancer Control, Therapeutic Studies, and Biomarker Sciences. As a result, 14 new trials have opened to patient enrollment since July 1, 2013. The wide array of scientific questions being explored in these trials reflects the group's expansive scientific aims. It also demonstrates the interactions across the 30+ committees and working groups involved--a cross-program integration that provides the members of ECOG-ACRIN with a dynamic multidisciplinary environment in which to pursue new scientific concepts. The 14 studies are listed below.
ACRIN 6702 - Detection
A Multi-Center Study Evaluating the Utility of Diffusion-Weighted Imaging for Detection and Diagnosis of Breast Cancer
Chair: Savannah Partridge, PhD (University of Washington)
Co-Chair: Habib Rahbar, MD (University of Washington)
Accrual goal: 100
Date activated: 01/14/2014
Anticipated completion: 01/2015

E2212 - Pancreatic Cancer
A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver
Chair: Steven K. Libutti, MD (Albert Einstein College of Medicine)
Co-Chair: Pamela L. Kunz, MD (Stanford University)
Accrual goal: 150
Date activated: 01/17/2014
Anticipated completion: 10/2016

Head and Neck
E3311 - Oropharynx Cancer Associated with HPV
Phase II Randomized Trial of Transoral Surgical Resection followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Chair: Robert L. Ferris, MD, PhD (University of Pittsburgh)
Co-Chair: Harry Quon, MD, MS (Johns Hopkins University)
Accrual goal: 377
Date activated: 07/09/2013
Anticipated completion: 10/2016
E1311 - Squamous Cell Carcinoma
A Randomized, Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence
Chair: Christine H. Chung, MD (Johns Hopkins University)
Co-Chair: Missak Haigentz, Jr., MD (Albert Einstein College of Medicine)
Accrual goal: 108
Date activated: 07/11/2013
Anticipated completion: 02/2016

E1910 - Acute Lymphoblastic
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-negative B Lineage Acute Lymphoblastic Leukemia in Adults
Chair: Mark R. Litzow, MD (Mayo Clinic)
Co-Chair: Ryan J. Mattison, MD (University of Wisconsin)
Accrual goal: 360
Date activated: 12/17/2013
Anticipated completion: 06/2018
E1912 - Chronic Lymphocytic
A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia 
Chair: Tait Shanafelt, MD (Mayo Clinic)
Co-Chair: Neil E. Kay, MD (Mayo Clinic)
Accrual goal: 519
Date activated: 01/31/2014
Anticipated completion: 04/2017 

E1412 - Diffuse Large B-Cell
Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma
Chair: Grzegorz S. Nowakowski, MD (Mayo Clinic)
Co-Chair: Thomas E. Witzig, MD (Mayo Clinic)
Accrual goal: 220
Date activated: 08/27/2013
Anticipated completion: 05/2015
PrE0401 - Non-Hodgkin
Phase II Randomized Trial Comparing GA101 (Obinutuzumab) and Rituximab in Patients with Previously Untreated Low Tumor Burden Indolent Non-Hodgkin Lymphoma
Chair: Stephen M. Ansell, MD, PhD (Mayo Clinic)
Co-Chair: Brad S. Kahl, MD (University of Wisconsin)
Accrual goal: 150
Date activated: 12/13/2013
Anticipated completion: 01/2015
E4412 - Hodgkin
A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma
Chair: Catherine M. Diefenbach, MD (New York University)
Co-Chair: Stephen M. Ansell, MD, PhD (Mayo Clinic)
Accrual goal: 30
Date activated: 01/24/2014
Anticipated completion: 03/2016

A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
Chair: F. Stephen Hodi, MD (Harvard University)
Co-Chair: Ahmad A. Tarhini, MD, PhD (University of Pittsburgh)
Accrual goal: 168
Date activated: 12/13/2013
Anticipated completion: 01/2016

Randomized Phase III Trial of Bortezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE)
Chair: Shaji K. Kumar, MD (Mayo Clinic)
Co-Chair: Adam D. Cohen, MD (University of Pennsylvania)
Accrual goal: 756
Date activated: 11/13/2013
Anticipated completion: 05/2016

E2512 - Non-Small Cell Lung Cancer
A Phase I / Randomized Phase II Study of Docetaxel with or without AZD4547 in Recurrent FGFR1-amplified Squamous Non-Small Cell Lung Cancer
Chair: Charles M. Rudin, MD, PhD (Johns Hopkins University)
Co-Chair: Melissa L. Johnson, MD (Northwestern University)
Accrual goal: 18 for phase I and 67 for phase II
Date activated: 09/09/2013 for phase I
Anticipated completion: 04/2016
ACRIN 4704 aka DECAMP-2 - Detection
Detection of Early Lung Cancer Among Military Personnel Study 2 (DECAMP-2): Screening of Patients with Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
Chair: Avrum Spira, MD, MSc (Boston University)
Co-Chair: Mitchell D. Schnall, MD, PhD (University of Pennsylvania)
Accrual goal: 880
Date activated: 09/10/2013
Anticipated completion: 09/2017
E2511 - Small Cell Lung Cancer
Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
Chair: Taofeek Owonikoko, MD, PhD (Emory University)
Co-Chair: Suresh S. Ramalingam, MD (Emory University)
Accrual goal: 150 for phase II
Date activated: 10/24/2013 for phase II
Anticipated completion: 01/2015
January 2014
In This Issue
NCORP Grant Submission
New Protocol ID System
Breast Committee Leadership
Dr. Benson Reflects
Young Investigator Symposium
FDA Filing for 3 New Trials
14 New Trials
Group Meeting Information
New Trial Education Pages
Recognitions and Distinctions
Carbone Fellowship Award
New Principal Investigators
E3F05 Suspended
In Case You Missed it...
ECOG-ACRIN on Twitter

Latest Group Meeting Information
The Spring 2014 ECOG-ACRIN Group Meeting will take place from Thursday morning, May 8th through Saturday evening, May 10, 2014, at the JW Marriot in Chicago, IL.  

Online registration for the upcoming meeting will open by early March. 


Attendees: Please remember the Thursday to Saturday format when making travel plans.


Now Posted. Future Dates and Locations

The group meeting dates and locations are set through 2015. Visit the Group Meetings section of the ECOG-ACRIN website for details. 
Now Posted:
New Educational Materials at
Recognitions and Distinctions...
Congratulations to lead author Michael J. Fisch, MD, MPH, and coauthors of the newly published manuscript "Predictors of Significant Worsening of Patient-Reported Fatigue Over a 1-Month Timeframe in Ambulatory Patients with Common Solid Tumors."
Their analysis on fatigue-worsening is distinguished on the cover of the February 2014 issue of CANCER. It draws upon data from E2Z02, the milestone survey of disease and treatment-related symptoms also known as the SOAPP study (for Symptom Outcomes And Practice Patterns).
The current issue of the Journal of Clinical Oncology contains an analysis from SOAPP data on the determinants of pain severity changes in ambulatory patients, authored by Fengmin Zhao, MS, PhD and colleagues. 


Applications Now Being Accepted for the 2014 Paul Carbone, MD Fellowship Award


The ECOG Research and Education Foundation is accepting applications through March 28, 2014 from hematology and oncology fellows interesting in being considered for this $25k research award.


View application instructions...

Members, please circulate this information at your site and/or pass along to any oncology fellow(s) you know who may be interested in applying.   


PI Committee Welcomes New Members

At its November 2013 meeting, the Principal Investigator (PI) Committee approved two roster changes.

At the Georgia Regents University Medical Center, Minority-based CCOP, Sharad A. Ghamande, MD, Assistant Professor, is the new designated PI to ECOG-ACRIN, replacing Anand P. Jillella, MD.

Dr. Jillella is now a Professor at Emory University and Associate Director of Community Outreach, Winship Cancer Center.

At Duke University, Daniel P. Barboriak, MD, Professor of Radiology, is the new designated PI to ECOG-ACRIN, replacing Terence Z. Wong, MD, PhD.

In late 2013, Dr. Wong was named by the University of North Carolina as Chief, Division of Nuclear Medicine; Director, Molecular Imaging, Biomedical Research imaging Center (BRIC); and Medical Director, BRIC.

Suspended: E3F05
ECOG-ACRIN has suspended new accrual to the trial E3F05: Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas. E3F05 was suspended due to updated findings from the Radiation Therapy Oncology Group (RTOG) trial 98-02. The findings were reported in a recent issue of the Journal of Clinical Oncology.
In Case You Missed It...
Recent Press Releases
ECOG-ACRIN Opens Trial E1912, Investigating Ibrutinib-Rituximab Combination in CLL

ECOG-ACRIN Announces the Opening of E1910, a Phase III Trial of Blinatumomab for Patients Aged 35-70 Years with Acute Lymphoblastic Leukemia
Increased Lymphocytic Infiltration in Tumor Stroma Linked to Improved Prognosis in Triple-Negative Breast Cancer 
Probability of Lung Cancer Overdiagnosis with LDCT Screening Addressed Using NLST Data


New Treatment Now Available That Extends Life in Men with Highly Advanced Prostate Cancer: Results from Trial E3805
ECOG-ACRIN Establishes Twitter Presence
ECOG-ACRIN has chosen @eaonc as its new Twitter handle. The group now uses its Twitter presence to increase awareness among patients and the public about clinical trials that are open and seeking patient participation. 


The group is beginning to coordinate its social media efforts with other network groups that, like ECOG-ACRIN, are members of the NCI National Clinical Trials Network. The goal is to cross-promote research activities among the network groups. 

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