From the Co-Chairs...

It is with enormous gratitude that we take this opportunity to acknowledge the many individuals across the ECOG-ACRIN membership for their contributions in the preparation of the numerous grant submissions made this month in response to the various Federal FOAs. Of course, from our vantage point, we observe the dramatic collective impact of your input each and every day, but even so, the tremendous collective brainpower that amassed around the submission process was truly impressive. 


For us, the process was an opportunity to look expansively across our Group. ECOG and ACRIN collectively contribute more than 65 years of experience to our combined program, which now focuses on the efficient development and implementation of practice-changing science along the cancer care continuum from early detection through the treatment of advanced disease. We leverage combined expertise in imaging, cancer biology, and therapy to develop treatment and advanced imaging trials that recognize the importance of biomarkers to identify appropriate patient subgroups for precisely targeted interventions. Our statistical centers, biorepositories, and image databases leverage the data collected in the context of trials to perform correlative science studies that advance our understanding of cancer biology and treatment effect. In fact, our response to the translational science FOA has opened up exciting new opportunities in our associated translational science centers. We continue to seamlessly integrate with Cancer Center and SPORE programs to create an interface for translating NCI-supported science into clinical trials and to attract junior investigators into the NCTN.


ECOG-ACRIN is positioned to make unique contributions to the NCTN, working to translate NCI-supported science into improved outcomes for cancer patients. But in the end, we can't lose sight of the fact that all of us, in one way or another, contribute to this effort for a very simple reason---to improve the lives of cancer patients.


We are very proud of you all, and we thank you.


Robert L. Comis, MD                 Mitchell D. Schnall, MD, PhD
Co-Chair                                      Co-Chair

Highlights from the Fall 2012 Group Meeting


The ECOG-ACRIN Fall 2012 Group Meeting, which was held November 9-11, 2012 in Hollywood, FL, had 775 attendees--a 26% increase over the 613 attendees who participated in the Fall 2011 Meeting. Nearly 70 committee meetings and education sessions convened over the 3-day period and were attended by member researchers and advocates affiliated with one or both of the founding groups.



Education Sessions at the Fall 2012 Group Meeting
As the new ECOG-ACRIN organization seeks to integrate the needs of its broadened base of imaging and clinical research professionals, many exciting changes are in the offing--including the transition to a new education track, which formally began at the ECOG-ACRIN Fall 2012 Group Meeting. Education sessions at the meeting were intended to further the knowledge of all professionals affiliated with clinical trials, and all registered attendees were welcomed and encouraged to attend. 

Promising Young Researchers Receive Distinction  

The ECOG-ACRIN Young Investigator Symposium, a mentoring program for promising new talent, took place in conjunction with the full ECOG-ACRIN 2012 Fall Group Meeting in November. Two Symposium presenters were honored with awards of distinction for their research--one in the clinical research category, and the other in the translational research category.



Reflections on the Carbone Fellowship Award
By David L. Bajor, MD
Dr. Bajor is a Hematology/Oncology Fellow in the Department of Medicine at the Perelman School of Medicine, University of Pennsylvania (Philadelphia, PA). He received the Paul Carbone, MD Fellowship Award in 2012. 
Receiving the Paul Carbone, MD Fellowship Award has been a tremendous personal honor, yet credit for this accomplishment truly belongs to my clinical and scientific mentors here at the University of Pennsylvania, my current home institution.The work acknowledged by the award focuses on pancreatic ductal adenocarcinoma (PDA), a disease in which improvement in standard of care has been slow to develop, and when an advancement does occur, it is often at the cost of high toxicity in patients.

Publication News

In this section, we provide abstracts of primary papers, along with high-impact articles associated with ECOG-ACRIN clinical trials. Five such articles were published in professional medical journals between November 1 and December 31, 2012.

NCI Transitions to Independent Protocol Review Model

On January 15, 2013, the National Cancer Institute (NCI) Central Institutional Review Board (CIRB) began a transition from its historic facilitated protocol review model to an independent protocol review model. In the independent protocol review model, the CIRB is the sole IRB of record and is responsible for both study review and review of local context considerations for enrolled institutions. It is expected that all institutions will be transitioned to the independent protocol review model by the end of 2013.


Mandatory Investigator Training Course for E3611



E3611, entitled "A Randomized Phase II Study of Ipilimumab at 3mg/kg or 10 mg/kg Alone or in Combination with High-dose Interferon-α in Advanced Melanoma,"was activated on December 27, 2012 and requires the accrual of 88 patients. The study will test the hypothesis that treatment with either a standard- or high-dose regimen of ipilimumab combined with high-dose interferon-α will improve progression-free survival in patients with advanced melanoma compared with ipilimumab alone.    


E3611 investigators must complete a onetime mandatory training course that provides information on the toxicity profile of ipilimumab prior to first patient enrollment. The course includes a self-paced presentation, multiple handouts, and a brief quiz developed by the study chairs. It is the same training course that was required for protocols E1608 and E1609; therefore, if training was completed for either of these protocols, it does not have to be completed again for E3611. Investigators may send an email to check their status. 


All ECOG-ACRIN members are welcome to complete the training course.The training course is available 24/7, so self-enroll here at your convenience. 

Trial Activations 
The following trial was activated between November 1 and
December 31, 2012:


A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-Alpha in Advanced Melanoma NCT01708941

Study Chair: Ahmad A. Tarhini, MD, PhD (University of Pittsburgh)

Accrual Goal: 88

Date Activated (Projected Completion): December 27, 2012 (July 2013)    

Trial Closures

The following trials were closed between November 1 and December 31, 2012:



ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) NCT00309985

Date Closed: November 21, 2012


GOG-0233/ACRIN 6671          

Utility of Preoperative FDG-PET/CT and Ferumoxtran-10 MRI Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced (IB2, IIA ≥ 4 CM, IIB-IVA) Carcinoma of the Cervix or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage NCT00416455

Date Cervical Arm Closed: December 3, 2012. The endometrial arm of the trial remains open.

Trials Approved, Soon To Be Activated

The following trials were approved between November 1 and December 31, 2012 (activation dates to come):



A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients with EGFR Wild-Type NSCLC NCT01708954 



A Phase I/Randomized Phase II Study of Docetaxel with or without AZD4547 in Recurrent FGFR1-Amplified Squamous Non-Small Cell Lung Cancer (not yet posted at



A Randomized Study of Temozolomide or Temozolomide+Capecitabine in Patients with Advanced Pancreatic Neuroendocrine Tumors (not yet posted at


Alliance A011104/ACRIN 6694          

Effect of Preoperative Breast MRI on Surgical Outcomes, Costs, and Quality of Life of Women with Breast Cancer (not yet posted at


RTOG 1201/ACRIN 6696    

A Phase II Randomized Trial of High versus Standard Intensity Local or Systemic Therapy for Unresectable Pancreatic Cancer (not yet posted at  



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 (not yet posted at



Randomized Phase III Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite Lenalidomide Maintenance in patients with Newly Diagnosed Symptomatic Multiple Myeloma (not yet posted at

January 2013
In This Issue
From the Co-Chairs
Fall Group Meeting Highlights
Fall Education Sessions
Distinction Awards
Carbone Award Reflections
Publication News
CIRB Transition News
E3611 Mandatory Training
Trial Activations
Trial Closures
Trials Approved
Latest Group Meeting Info
Young Investigator Award
E2410 Imaging Info
Attn. Community-based Sites!
Now Posted: E3611 Material
Oncology Fellows, Apply Now!
newsletter sign up
Latest Group Meeting Info

The Spring 2013 Group Meeting will be held mid afternoon Thursday, May 16 to mid afternoon Saturday, May 18, 2013 in Atlanta, GA.

Attendees: Please note the new Thursday to Saturday format before making travel plans.

View the Group Meetings page for new information as it becomes available.
Attention Principal Investigators:

Your nominations for the 2013 Young Investigator Award are due by April 19, 2013.

Need Answers to E2410 Imaging Questions? ACRIN Personnel Ready to Respond

E2410, a phase 2 study of response-adapted chemotherapy based on positron emission tomography (PET) in patients with unfavorable stage I/II Hodgkin's lymphoma, is currently recruiting patients.


The design of E2410, the first joint clinical trial of ECOG-ACRIN, enables the integration of interim PET scans into the decision-making process of treating patients. Although many ECOG sites have some experience with imaging studies, obtaining the imaging qualifications needed to participate in E2410 could be a challenge for sites new to the process. Personnel from ACRIN recognize these challenges and are available to provide sites with information and support.


For questions regarding PET/computed tomography (CT) review, PET scanner image qualification, and image submission, contact ACRIN personnel:


Rebecca DiGati 

(215) 574-3175


Donna Hartfeil 

(215) 717-2765


Numerous other resources are available to help healthcare professionals and patients learn more about E2410. Educational materials are publicly accessible at the E2410 Trial Education page.

Attention Community-based Sites! Are You Qualified for Imaging Studies?


Are you interested in championing participation in clinical trials with imaging aims at your site? If so, contact us now! The ECOG-ACRIN Cancer Research Group has personnel in place to provide all of the guidance and support you need to participate in imaging research, including scanner qualification, image submission, and other imaging-specific research requirements. 


Read Dr. Schnall's Open Letter...

Now Posted:
E3611 Education Materials
Oncology Fellows, Please Apply!

Applications for the 2013 Paul Carbone, MD Fellowship Award are being accepted through April 5th.

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