MS/AL Radiation Oncology Research Partnership W. Sam Dennis, MD, PhD P.I., Singing River Hospital System Sharon Spencer, MD P.I., University of Alabama – Birmingham Maggie Clarkson, RN, MS Grants Program Director, Singing River Hospital System

MS/AL RADIATION THERAPY RESEARCH PROGRAM STAFFING PLAN SRHCCUABCCC P.I. – Dennis (10%) P.I. - Spencer CO – P.I.GRANTS ADMIN (.5 FTE)PROGRAM DIRECTOR (1 FTE) Clarkson (3%) Hull (3%) Sariego (2.5%) Lyell (2.5%)RESEARCH STAFFOUTREACH STAFF (*)PATIENT NAVIGATORS Research Nurse (1 FTE)Health Educator/RN (1 FTE)Patient Advocate/Van Driver (2 FTE) Data Manager(1 FTE) CONTRACT: $ /year * Shared oversight with Director, Community and Corporate Wellness Program

Partnership/Mentor Relationship Program Steering Committee Scientific Review Committee TeleSynergy programs Investigator-initiated Studies Workshops for investigators and grant staff Medical and Support Staff training opportunities

Clinical Research Development of Activation Prioritization List for Cooperative Group Studies: RTOG, SWOG, NSABP, GOG, CTSU –Patient Population Data for SRHS-RCC reviewed against Active studies listings for study groups and: Scientific questions of interest for medical staff Standard treatment remains sub-optimal for site/stage Treatment regimens inclusive of RT Annual Accrual Goals Long-term Clinical Research Office Goals

SINGING RIVER HOPSITAL REGIONAL CANCER CENTER – OPEN CLINICAL TRIALS LIST ANAL/RECTAL RTOG 0315A Randomized Double Blind Placebo-controlled Phase III Study to Determine the Efficacy of Sandostatin Lar Depot (Octreotide Acetate) in Preventing or Reducing the Severity of Chemoradiation-Induced Diarrhea in Patients with Anal or Rectal Cancer. (IRB ok 9/20/05) BREAST NSABP B-35A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with Ductal Carcinoma In Situ (DCIS) Undergoing Lumpectomy with Radiation Therapy (IRB ok 4/12/06) NSABP B-36A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC) in Patients with Node-negative Breast Cancer (IRB ok 10/11/05) NSABP B-38A Phase III, Adjuvant Trial Coparing Three Chemotherapy Regimens in Women with Node-positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-dense (DD) Doxorubicin/Cyclophosphamide followed by DD Paclitaxel (DD AC→P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC→PG) (IRB ok 10/11/05) SWOG S0221Phase III Trial of Continuous Schedule AC + G vs. Every 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-operative Adjuvant Therapy in Node-positive or High-risk Node-negative Breast Cancer (IRB ok 10/11/05) COLON NSABP C08A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (mFOLFOX6) every Two Weeks with Bevacizumab to the Same Regimen without Bevacizumab for the Treatment of Patients with Resected Stages II and III Carcinoma of the Colon. (IRB ok 9/20/05) LUNG SWOG S9925SWOG S9925Lung Cancer Specimen Repository Protocol, Ancillary (IRB ok 10/11/05) PROSTATE RTOG 0126A Phase III Randomized Study of High Dose 3D-CRT/IMRT versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized Prostate Cancer (IRB ok 9/20/05)

Investigator-Initiated Studies Phase I/II Trial of Alternative Dose Schedule of 1650cGy in 3 fractions for Palliative Radiation treatment of Bone Metastases Development of Geriatric Assessment Profile to Support Accrual of Elderly Patients onto Clinical Research Trials Impact of Cancer Screening Recruitment Model using Prior Participants as Advocates Among Minorities ?? Immobilization Methods for Prostate IMRT ?? Geriatric Oncology Issues

Community Involvement Focus Internal –Community & Corporate Wellness –Pharmacy/Social Services/Dietary/PT/OT/Financial Services –Transportation External –Health-related Organizations –Faith-based Organizations –Business/Corporate –Civic/Community Service Organizations –Educational Institutions Medical Community –Focus on Clinical Research Issues –Cancer Center referral base

Patient Navigator Services Team approach with oncologist/RN –Involvement post-treatment planning Supportive needs assessments –Document categories of needs –Referrals to internal/external resources Transportation assistance using van Assist with Community Outreach programs Monitor outcomes

Community Outreach Focus on minorities and underserved Develop cancer control education/awareness/screening activities appropriate to specific target populations Develop outcomes measures/monitoring methods to determine impact on participation in risk reduction activities Develop ongoing cancer patient education programs and services for SRHS Facilitate/coordinate support group activities Support development of patient advocacy program

Impact of Hurricane Katrina on Our Community: The Good, The Bad, the Ugly