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

 

 

SRHCC UABCCC

 

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 STAFF OUTREACH STAFF (*) PATIENT NAVIGATORS

Research Nurse (1 FTE) Health Educator/RN (1 FTE) Patient Advocate/Van Driver (2 FTE)

Data Manager (1 FTE)

 

 

CONTRACT: Biostatistician @ $5000.00/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

Disease Site Stage2003 Pt.

Caseload RTOG SWOG NSABP CTSU

Breast DCIS 14 0214*, 9804* B-35

I 20 NCICMA.20**S0221 , S0230, MA.20**

B-36 , MA.20**

CALGB 49907**

IIAS0221 S0230(premeno) B-36

CALGB 49907**

IIB S0012, S0221 , S0230 B-38CALGB 49907**

IIIA S0012, S0221 , S0230CALGB 49907**

IIIB S0012, S0221CALGB 49907**

IV 1 S0215, S0226, S0347

Bladder 0 7

I 5 S0219**

II 4 0524, 0233 4B951

III 1 0524, 0233 4B951

IV 0 0524, S0028, S0306, S0400

Colon I 10

II 5 C-08III 5 C-08 N0147

IV 4

Head/Neck I 5(3*) 0225 (IMRT)

* larynx II 2 0225 (IMRT)

III 2 (1*) 0225 (IMRT)

IV 5 (2*) 0234, 0421, 0225

Lung (NSC) I 13 0236, 0117 RTOG 0127/E5597

II 2 0236, 0117

III 11 0117, 0229, 0214* S0332/RTOG 0412

IV 23 320 S0342

Lung (SC) I 2 0241, 0239**, 0212

II 1 0241, 0239**, 0212

III 4 0241, 0239**, 0212

IV 2 S0124

17

4

Disease Site Stage2003 Pt.

Caseload RTOG SWOG NSABP

Lymphomaprimary CNS 0227 (pre-RT chemo)

NHL I 1 S0313

II 4 S0016, S0313

III 0 S0213, S0349

IV 1 S0213, S0349

Pancreas I 0

II 1

III 10411*, RTOG/ECOG 4201

IV 3 S0205

Prostate I 1 0232, 0321 S9921

II 56 0232, 0126 JPR3, JPR7

III 11 0321, JPR3, JPR7

IV 5JPR3, JPR7, S0418, SWOG/CALGB 90202

Rectal I 5

II 3 0247* (neoadj) R04

III 0 0247* (neoadj) S0304

IV 2 S0304symptom control 0315 (diarrhea)

Sarcoma I 2

II 0 0330,

III 0 0330,

IV 2

 

SINGING RIVER HOPSITAL REGIONAL CANCER CENTER – OPEN CLINICAL TRIALS LIST

ANAL/RECTAL RTOG 0315 A 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-35 A 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-36 A 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-38 A 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 S0221 Phase 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 C08 A 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 S9925 SWOG S9925 Lung Cancer Specimen Repository Protocol, Ancillary (IRB ok 10/11/05) PROSTATE RTOG 0126 A 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