This application represents the first competitive renewal of the CALGB institutional grant submission from the University of North Carolina at Chapel Hill (UNC-CH) and its affiliates. UNC-CH has been a member of CALGB since 1986 and currently ranks at least in the top third of Group institutions as judged by any yardstick, but only received NCI institutional support through out-of-cycle review and Type 5 redistribution this past year. Previous reviews have praised the excellent science and leadership represented by the UNC-CH membership as well as our data management and quality assurance. We have continued our rapid accrual expansion to nearly 200 cases in 1991. Moreover, our institution now has broad leadership participation in the Group in virtually every committee and is the research base for a Minority CCOP. We have increased accrual to Phase I, II, III and companion studies to a level that is well above the average of other outstanding institutions in the Group. Secondly, we have added major affiliates that have achieved 50% of our 1991 accrual while maintaining excellent data quality control and have established rigorous internal audit and quality assurance procedures. In 1992, we will add several new affiliates with the future capacity to accrue between 50-100 additional cases (including a high proportion of minority cases) to our current baseline of 200. Third, our leadership efforts in the Group have also continued to expand. We now enjoy the distinction of having two committee chairs, three committee vice-chairs, sixteen committee core members, two Executive Committee members, more than 20 protocol principal investigators or co- investigators and three members of the Board of Directors. In addition, the efforts of UNC-CH through CALGB were instrumental in leading to the Minority CCOP award to Chris Desch of our affiliate, MCV and funding of his Minority CCOP Program in Southern Virginia, which uses UNC-CH as its research base. Our overall minority accrual to all CALGB studies remains at five times the national average at 25% and our accrual of women is 58% compared to the Group average of 53%. We plan to continue direct service to the Group by first of all maintaining an active reference laboratory in molecular epidemiology involving leukemia, myelodysplasia, breast and colorectal studies. We have further broadened Group science by the addition of companion studies in myelodysplasia, AML and breast cancer designed by Edison Liu, Dale Sandler, Robert Sandler and Paul Godley, some with independent funding. Previous and new members of our institution have continued to expand our contribution to Group scientific and administrative committees and studies (H. Ozer, Executive Committee, Leukemia Core, Lymphoma core, PET Core, Biotherapy vice-Chair, Industrial Relations Core; K. Rao, Cytogenetics Core; J. Tepper, Radiation Oncology Core, Executive Committee, GI Vice-Chair; Gavigan, Data Audit Core, Oncology Nursing Chair; D. Sandler, Epidemiology Chair, Correlative Science Core; E. Liu, Correlative Science core; T. Shea, Transplant core; J. Rosenman, Radiation Oncology core; R. Sandler, Epidemiology; P. Godley, Minority Consortia). Additional faculty at UNC-CH will expand our commitment and Group leadership in the Breast and Surgery committees (J. Huth, W. Cance, M. Graham, J. Mohler); Radiation Therapy (S. Sailer), Epidemiology (P. Godley), Cancer Prevention and Control Sciences (R. Sandler) and GU (P. Godley). We therefore believe that this application reflects the growing and crucial contribution that UNC-CH investigators provide to the Group in leadership, science and service and confirms our energetic efforts to increase accrual through the addition of major affiliates with rigorous control of quality data submission.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA047559-04
Application #
2092635
Study Section
Cancer Clinical Investigation Review Committee (CCI)
Project Start
1991-06-01
Project End
1998-03-31
Budget Start
1994-04-01
Budget End
1995-03-31
Support Year
4
Fiscal Year
1994
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Morrison, Vicki A; McCall, Linda; Muss, Hyman B et al. (2018) The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). J Geriatr Oncol 9:228-234
Li, Megan; Mulkey, Flora; Jiang, Chen et al. (2018) Identification of a Genomic Region between SLC29A1 and HSP90AB1 Associated with Risk of Bevacizumab-Induced Hypertension: CALGB 80405 (Alliance). Clin Cancer Res 24:4734-4744
Campbell, Jeffrey I; Yau, Christina; Krass, Polina et al. (2017) Comparison of residual cancer burden, American Joint Committee on Cancer staging and pathologic complete response in breast cancer after neoadjuvant chemotherapy: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat 165:181-191
Giuliano, Armando E; Ballman, Karla V; McCall, Linda et al. (2017) Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA 318:918-926
Mandelblatt, Jeanne S; Cai, Ling; Luta, George et al. (2017) Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance). Breast Cancer Res Treat 164:107-117
Freedman, Rachel A; Foster, Jared C; Seisler, Drew K et al. (2017) Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. J Clin Oncol 35:421-431
Himelstein, Andrew L; Foster, Jared C; Khatcheressian, James L et al. (2017) Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA 317:48-58
Kimmick, Gretchen G; Major, Brittny; Clapp, Jonathan et al. (2017) Using ePrognosis to estimate 2-year all-cause mortality in older women with breast cancer: Cancer and Leukemia Group B (CALGB) 49907 and 369901 (Alliance A151503). Breast Cancer Res Treat 163:391-398
Holstein, Sarah A; Jung, Sin-Ho; Richardson, Paul G et al. (2017) Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial. Lancet Haematol 4:e431-e442
Basch, Ethan; Dueck, Amylou C; Rogak, Lauren J et al. (2017) Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials. JAMA Oncol 3:1043-1050

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