astro 2004 cdrp annual symposium expanding clinical trials participation
DESCRIPTION
ASTRO 2004 CDRP 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. Univ. of Wisconsin, Madison, WI. - PowerPoint PPT PresentationTRANSCRIPT
ASTRO 2004CDRP Annual Symposium Expanding Clinical Trials
Participation
ASTRO 2004CDRP Annual Symposium Expanding Clinical Trials
Participation
Daniel G. Petereit, MDRapid City Regional Hospital
Rapid City, SD
Bobby Bains, MDLaredo Medical Center
Laredo, Tx
Michael Steinberg, MDDaniel Freeman Hospital
Inglewood, CA
Daniel G. Petereit, MDRapid City Regional Hospital
Rapid City, SD
Bobby Bains, MDLaredo Medical Center
Laredo, Tx
Michael Steinberg, MDDaniel Freeman Hospital
Inglewood, CA
Clinical Center, NIH
Holy Cross Hospital, Fort
Lauderdale, FL
UPMC McKeesport
Hospital, McKeesport,
PA
Mercy Hospital, Laredo, TX
Univ. Texas Health Science Center, San
Antonio, TX
Daniel Freeman Memorial Hospital,
Inglewood, CA
Univ. of Wisconsin,
Madison, WI
Rapid City Regional Hospital, Rapid
City, SD
Singing River Hospital,
Pascagoula, MS
USC, California
Univ. Pittsburgh
Medical Center,
Pittsburgh, PA
National Navy Medical Center, Bethesda, MD
UNC Chapel Hill, Chapel Hill, NC
Univ. of Alabama, Tuscaloosa, AL
Children’s National Medical Center, Washington, DC
New Hanover Regional Medical
Center, Wilmington, NC
Wheeling Hospital, WV
CDRP SitesCDRP Sites
Expanding Clinical Trials ParticipationExpanding 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, H&N
• 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, H&N
RTOG 0321- HDR Brachytherapy Intermediate-Risk Prostate Cancer
Daniel Freeman Trial
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
• 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
HDR Brachytherapy Intermediate-Risk Prostate Cancer
Rapid City Trial
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
• 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
Rapid City HDR Prostate Study
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%)
• 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%)
John T. Vucurevich Cancer Care InstituteJohn T. Vucurevich Cancer Care Institute
RAPID CITYREGIONAL HOSPITALRAPID CITYREGIONAL HOSPITAL
Phase I/II Tomotherapy Prostate Trial
Phase I/II Tomotherapy Prostate Trial
4.3
Š 50 PTS Š 50 PTS Š 50 PTS
UW / Rapid City Trial
•Level 1: 50 patients, modest acute toxicities•G2 rectal toxicities: 2•Level II: 1 patient
Daniel Freeman Trials Other RTOG Trials
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
• 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
Daniel Freeman Trials Other Trials
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
• 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
Daniel Freeman Trials Other Trials
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
• 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
Phase II Trial HDR Brachytherapy Stage I and II Breast Carcinoma
Rapid City Trial
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 < 3 cm, NO, N1 (1-3 LNs)
• 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
• 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 < 3 cm, NO, N1 (1-3 LNs)
• 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
CTSU Regional RT Breast TrialLaredo Trials
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 (<10 or ≥10)
Centre
STRATIFY
# of positive nodes (0,1-3,>3)
Type of chemotherapy (anthracycline, other, or none)
Hormonal therapy (yes, no)
# of axillary nodes removed (<10 or ≥10)
Centre
Radiation to Breast, Ipsilateral Axilla, Supraclav and Internal Mammary Lymph nodes
Radiation to Breast, Ipsilateral Axilla, Supraclav and Internal Mammary Lymph nodes
Randomize
Radiation only to Breast
Bobby Bains, MDBobby Bains, MD
Phase III Trial WBRT + Thalidomide (RTOG) Laredo Trials
Phase III Trial WBRT + Thalidomide (RTOG) Laredo Trials
STRATIFY
RPA Class (good features vs adverse)
Chemotherapy after XRT planned (yes or no)
STRATIFY
RPA Class (good features vs adverse)
Chemotherapy after XRT planned (yes or no)
Whole Brain Radiation alone 37.5 Gy in 2.5 Gy fractions over 3 weeks.
Whole Brain Radiation alone 37.5 Gy in 2.5 Gy fractions over 3 weeks.
Randomize
Oral Thalidomide + Whole Brain Radiation 37.5 Gy in 2.5 Gy Fx over 3 weeks
Bobby Bains, MDBobby Bains, MD
Ataxia Telangiectasia UW / Rapid City Trial
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 38:200-8, 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
• ATM mutations in female breast cancer patients may predict for an increase in radiation-induced late effects.
– Atencio DP et al. Environmental & Molecular Mutagenesis 38:200-8, 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
ATM MUTATIONS in Native Americans: Possible Association with Cancer and
Radiotherapy Toxicities
UW / Rapid City Trial
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
• 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
Obtaining Approval Indian Health ServiceObtaining 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
• 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
Protocol Timeline 2003 - 2004Protocol Timeline 2003 - 2004A
AIR
B
Prot 6: Tomo Prostate
Prot 3: Community SurveyProt 4: Navigator
Prot 2/1: Breast Brachy - NAI
Prot 5: Tomo Bone
Prot 1/1: Prostate Brachy - NAI
Prot 3: Community Survey
Nat
.IR
B
Prot 2/1: Breast Brachy - NAI
Prot 4: NavigatorProt 5: Tomo Bone
Prot 1/1: Prostate Brachy - NAI
Prot 6: Tomo Prostate
UW
IR
B
Prot 2/1: Breast Brachy - NAI
Prot 5: Tomo BoneProt 2/2: Breast Brachy
Prot 1/1: Prostate Brachy - NAIProt 1/2: Prostate Brachy
Prot 6: Tomo Prostate
Prot 2/1: Breast Brachy - NAI
RC
RH
IR
BProt 1/1: Prostate Brachy - NAI
Prot 5: Tomo Bone
Prot 3: Community SurveyProt 4: Navigator
Prot 2/2: Breast Brachy
Prot 1/2: Prostate Brachy
Prot 6: Tomo Prostate
Submitted
Approved withfinal letter
Ready to enroll after NCI appr.
Sep
tem
ber
03
Oct
o be r
03
Feb
ruar
y 04
Mar
c h 0
4
Apr
il 04
Nov
emb
e r 0
3
Dec
emb
e r 0
3
Janu
ary
0 4
May
04
June
04
Aug
ust
03
July
03
June
03
Sep
tem
ber
04
Aug
ust
04
July
04
Goal of Research GrantGoal 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.
Through the use of technologically advanced radiation delivery systems, the potential exists that some treatment barriers will be lowered, and therefore, cure rates enhanced.