ASTRO 2004 CDRP Annual Symposium Expanding Clinical Trials Participation

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ASTRO 2004CDRP Annual Symposium Expanding
Clinical Trials Participation

• Daniel G. Petereit, MD
• Rapid City Regional Hospital
• Rapid City, SD
• Bobby Bains, MD
• Laredo Medical Center
• Laredo, Tx
• Michael Steinberg, MD
• Daniel Freeman Hospital
• Inglewood, CA

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CDRP Sites
UPMC McKeesport Hospital, McKeesport, PA
Rapid City Regional Hospital, Rapid City, SD
Univ. Pittsburgh Medical Center, Pittsburgh, PA
Childrens National Medical Center, Washington, DC
USC, California
Univ. Texas Health Science Center, San Antonio, TX
Mercy Hospital, Laredo, TX
Univ. of Alabama, Tuscaloosa, AL
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Expanding Clinical Trials Participation

• Increasing minority access and enrollment on
  clinical trials
• Major metric CDRP program
• Cooperative group trials
• RTOG partner with CDRP program
• Other cooperative group trials
• CTSU mechanism
• GOG, ECOG,NSABP, etc
• CDRP trials
• Prostate, breast, lung, HN

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RTOG 0321- HDR Brachytherapy Intermediate-Risk
Prostate Cancer Daniel Freeman Trial

• Intermediate risk patients
• 45 Gy EBRT, HDR boost 19 Gy 2 fractions
• Primary goal determine Grade 3 or greater GU
  and GI toxicities
• Secondary goal FFR, OS, and DFS
• N 110
• Michael Steinberg, MD

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HDR Brachytherapy Intermediate-Risk Prostate
Cancer Rapid City Trial

• PI Daniel Petereit, MD Co-PIs Jack Fowler,
  PhD, Mark Ritter, MD, PhD, Richard Chappell, PhD
• Patient eligibility intermediate, high-risk
  prostate cancer
• Androgen ablation 6 to 12 months
• EBRT 2.2 Gy x 16 over 15 treatment days, HDR
  6.5 Gy x 3
• Endpoints
• Evaluate the rate acute, late toxicities
• Enhance the participation of Native Americans on
  clinical trials
• Influence stage at presentation
• Efficacy HDR boost
• 50 pts Rapid City
• CDRP study Rapid City, Laredo, others

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Rapid City HDR Prostate Study

• 81 patients
• Low, Intermediate, High 25, 40, 35
• Median F/U 4 years
• 45 Gy WP, 5.5 6.5 Gy in 3 to 4 Fx
• 5 failures
• Overall 92 bNED
• Low, Intermediate, High 100, 95, 85
• Urethral stricture rate 5 (6)

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Phase I/II Tomotherapy Prostate Trial
UW / Rapid City Trial

• Level 1 50 patients, modest acute toxicities
• G2 rectal toxicities 2
• Level II 1 patient

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Daniel Freeman Trials Other RTOG Trials

• RTOG 0232- Phase III Study comparing combined
  EBRT and PSI with brachytherapy alone for select
  intermediate prostatate CA
• RTOG 0247- Randomized phase II trial of
  neoadjuvant combined modality therapy for locally
  advanced rectal cancer
• Michael Steinberg, MD

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Daniel Freeman Trials Other Trials

• RTOG 9804- Phase III trial of observation/-
  tamoxifen vs RT /- tamoxifen for good risk
  (DCIS)
• RTOG 0214- A Phase III comparison of PCI versus
  observation in patients with locally advanced
  non-small cell cancer
• Michael Steinberg, MD

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Daniel Freeman Trials Other Trials

• Mammosite DCIS Trial- To determine the toxicity
  and local control with Mammosite brachytherapy
  for DCIS
• P4 Prostate Profile Project To develop a
  data/tissue/blood/specimen/anatomical part/cell
  line repository that can be used for studying the
  biology, etiology, genetics, and pharmacogenetics
  of prostate cancer and related diseases
• Michael Steinberg, MD

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Phase II Trial HDR Brachytherapy Stage I and II
Breast Carcinoma Rapid City Trial

• PI Daniel Petereit, MD Co-PIs Scott
  Tannehill, MD, Jack Fowler, PhD, Richard
  Chappell, PhD
• Western, South Dakota historically, very low
  breast conservation rate
• Tumors
• 34 Gy/10 Fxs, or 32 Gy/8 Fxs
• Endpoints
• Evaluate the rate acute, late toxicities
• Enhance the participation of Native Americans on
  clinical trials
• Influence stage at presentation
• Efficacy, local control, cosmesis
• 50 pts
• DSMB
• Parallel study open enrollment
• CDRP study

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CTSU Regional RT Breast TrialLaredo Trials

• STRATIFY
• of positive nodes (0,1-3,3)
• Type of chemotherapy (anthracycline, other, or
  none)
• Hormonal therapy (yes, no)
• of axillary nodes removed (
• Centre

Randomize

• Radiation to Breast, Ipsilateral Axilla,
  Supraclav and Internal Mammary Lymph nodes

Radiation only to Breast
Bobby Bains, MD
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Phase III Trial WBRT Thalidomide (RTOG) Laredo
Trials

• STRATIFY
• RPA Class (good features vs adverse)
• Chemotherapy after XRT planned (yes or no)

Randomize

• Whole Brain Radiation alone 37.5 Gy in 2.5 Gy
  fractions over 3 weeks.

Oral Thalidomide Whole Brain Radiation 37.5 Gy
in 2.5 Gy Fx over 3 weeks
Bobby Bains, MD
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Ataxia Telangiectasia UW / Rapid City Trial

• ATM mutations in female breast cancer patients
  may predict for an increase in radiation-induced
  late effects.
• Atencio DP et al. Environmental Molecular
  Mutagenesis 38200-8, 2001
• 46 patients, breast conservation, HPLC ID genetic
  variants
• 9 ATM mutations 6 patients
• A significant correlation between ATM mutation
  status and the development of Grade 3-4
  subcutaneous late effects
• All 3 of the patients (100) who manifested Grade
  3-4 subcutaneous late sequelae possessed ATM
  mutations, whereas only 3 (7) of the 43 patients
  who did not develop this form of severe toxicity
  harbored an ATM mutation

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ATM MUTATIONS in Native Americans Possible
Association with Cancer and Radiotherapy
Toxicities UW / Rapid City Trial

• Exploratory pilot study to compare the baseline
  incidence of ATM heterozygosity of Native
  Americans with cancer, who are undergoing
  radiation therapy, to a similar group of
  non-Native Americans.
• To determine the association between ATM
  heterozygosity and sensitivity to radiation.
• University of Wisconsin Mark Ritter, MD,PhD Amy
  Moser, PhD Roger Wiseman, PhD

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Obtaining Approval Indian Health Service

• Dilemma seeking approval nation, not just an
  individual
• Required process
• Resolution from Tribal Health Council
• Letter from Service Unit Director
• Resolution from Aberdeen Area Tribal Chairmens
  Health Board
• Each requires special meeting and presentation
  and packet of summary materials
• Each protocol
• 4 Native American Populations
• NINE LETTERS OR RESOLUTIONS
• Total 6 protocols
• 54 LETTERS/RESOLUTIONS

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Protocol Timeline 2003 - 2004
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Goal of Research Grant

• Through the use of technologically advanced
  radiation delivery systems, the potential
  exists that some treatment barriers will be
  lowered, and therefore, cure rates enhanced.