-
Walter J Curran, Jr, MD
Executive Director
Winship Cancer Institute of Emory University
RTOG Group Chairman
Is Multi-Center Innovative Research
Possible? RTOG as a Case Study in 2012
The Luther Brady Lecture/Discussion
-
RTOG Overview
• Organization & Administration
• Research Initiatives & Strategic Themes
• RTOG’s Unique Characteristics
• New Cooperative Group Changes
-
What is the RTOG?
What is the RTOG?
• The lead multicenter organization prospectively testing novel radiotherapy
approaches against cancer and pursuing fully
integrated translational research to support
and further this effort.
-
RTOG History
• Forty-four Year History of NCI Funding
• Four Group Chairs
– Simon Kramer
– Luther Brady
– James Cox
– Walter Curran
• Administered via American College of Radiology
-
RTOG:
Current Infrastructure Strengths1. Engagement of Nearly All NCI-Designated Cancer
Centers and Canadian Centers
2. Strong IT/Imaging/QA Infrastructure within ACR
(ACRIN)
3. Excellent Statistics/Data Management/Administration
4. Inclusive Decision-Making Processes
5. Growing Private Partnerships
6. Outstanding Biospecimen Repository at UCSF
7. Unique Capacity to Interrogate Data from Prior Trials
-
Essential Elements for Success??
A Very Partial List!!!
• Committed Physician Leaders & Members
• Committed Research Ass’ts, Nursing, Physics, etc
• Creative but Achievable Research Ideas
• Outstanding Infrastructure
• Sufficient Resources
• Available and Willing Patient Participants
-
National/International Theater for the RTOG
• NCI Funding for Cooperative Agreement
• NIH Supplemental Funding
• NCI Approval of Trial Concepts
• Pharmaceutical/Industry Support of Research
• Selection of Group to Test New Therapies
• Precious Time and Ideas of National Leaders
• Opportunity to Mentor Young Investigators
-
Local/Regional Theater of RTOG Activity
• Specialty-Specific Time/Interest
• Broader Interest by All Caregivers
• Space in Institutional Protocol Portfolio
• Budgetary Permission for Trial Deficits
• MD’s to both Follow as well as Lead
• Buy-in by Academic and Community Groups
-
Local/Regional Theatre Competition: Case Studies
• New RTOG-Oriented Leadership
– UT Southwestern, Case Western, Memorial SKCC
• Canadian Participation
• Departure of RTOG-Oriented Leadership
– Fox Chase, Jefferson, Michigan, Mass General
• State of Georgia Story
-
RTOG Disease Site Committees/Working Groups*
Cancer Disease Site Chair
• Brain Tumors Minesh Mehta, MD
• Head & Neck Cancer Quynh Le, MD, PhD
• Lung Cancer Jeffrey Bradley, MD
• Gastrointestinal Cancer Christopher Crane, MD
• Genitourinary Cancer Howard Sandler, MD
• Breast Cancer* Julia White, MD
• Gynecologic Cancer* David Gaffney, MD, PhD
• Sarcoma* Burton Eisenberg, MD
-
RTOG Scientific Core Committees
• Advanced Technology Integration Jeff Michalski, MD
• Health Services Research Deborah Bruner, PhD
• Translational Research Program Adam Dicker, MD, PhD
• Biospecimen Resource Richard Jordan, MD, PhD
• Pathology Tony Magliocco, MD
• Medical Oncology Corey Langer, MD
• Medical Physics Michael Gillin, PhD
• Surgical Oncology Peter Pisters, MD
-
RTOG Funding SupportATC QA
Center
2%
Other Grants
%PA C.U.R.E.
4%
Corporate
6%
Tissue Bank
4%
RTOG HQ
Grant
52%
CCOP
11%
SDMC
5%
RTOG
Foundation
15%
< 1
-
Number of RTOG Studies
Open to Accrual 2006 - 2011
37
4446
52
46 47
0
10
20
30
40
50
60
2006 2007 2008 2009 2010 2011
-
Number of RTOG Protocol Activations/Yr
10
-
2011 Top Accruing RTOG
Full & Provisional Institutions
• US Oncology 64
• Wash U 61
• UH Cleveland/Case 54
• McGill U 53
• Emory U 51
• MSKCC 47
• MD Anderson 46
• Med C Wisconsin 44
• Roswell Park 40
• RA Sacramento 40
-
Current Cooperative Group Heat Map
3,100
Institutions
14,000
Investigators
About
25,000 pts
enrolled on
tx trials
annually
Trials FY2006 FY2007 FY2008 FY2009 FY2010
All Phases:
Treatment
Trials
27,667 24,715 25,784 29,285 23,468
-
RTOG Total Accrual
31582980
2562 2675
3127
0
500
1000
1500
2000
2500
3000
3500
2006 2007 2008 2009 2010 2011
2737
-
RTOG Research Initiatives & Strategic Themes
• Physical Targeting
• Molecular Targeting with RT or ChemoRT
• Translational and Analytic Research
-
Research Initiatives & Strategic Themes
• Physical Targeting
• Molecular Targeting with RT or ChemoRT
• Translational and Analytic Research
-
Physical Targeting
• RTOG will implement and test advances in imaging and high-precision radiation planning and delivery
technologies in clinical trials.
• This work will lead to meaningful improvements in therapeutic ratio for our patients.
-
Physical Targeting
Tremendous Biophysical Advances
• Functional Imaging
• Image-Guided RT
• RT Planning & Delivery
• Data Transfer & Analysis
-
Physical Targeting
Enhanced Infrastructure
• Advanced Technology Integration Committee (ATIC)
– New Name, New Mission
• Effective Liaisons between Disease Site, ATIC, and Medical
Physics Committees
• Co-Development of Trials with ACRIN
• Creation of RT Core Lab at RTOG HQ
• Increase in Resources for New Technology Accreditation
-
Physical Targeting
Enhanced Infrastructure
• Advanced Technology Integration Committee (ATIC)
– New Name, New Mission
• Effective Liaisons between Disease Site, ATIC, and
Medical Physics Committees
• Co-Development of Trials with ACRIN
• Creation of RT Core Lab at RTOG HQ
• Increase in Resources for New Technology Accreditation
-
Technology Enabling SBRT
-
New RTOG Website
-
Selected Achievements: Completed Trials
Physical Targeting: RTOG Trials
• Clarify the Role of Radiosurgery
–Survival Benefit in Brain Oligometastases
–No Benefit for Glioblastoma Multiforme
• Outstanding Tumor Control with High Tech RT Alone
–SRT for Medically Inoperable NSCLC Patients
– IMRT for Intermediate Stage Oropharyngeal Cancer
• Feasibility with Intensified RT with Concurrent Chemo
–RT Dose Escalation for NSCLC
–Accelerated Fractionation RT for Limited Stage SCLC
-
RTOG 9508 Phase III Single Brain Mets: Survival
RT + SRS (Median survival = 6.5 mo)
RT alone (Median survival = 4.9 mo)
P=0.0470
100
80
60
40
20
0
0 6 12 18 24Months
Per
cen
t a
live
-
Ongoing Initiatives RTOG Research in Physical Targeting
• Integration/Study of IMRT for Prostate Cancer
• Phase III Partial Breast RT Trial with NSABP
• Phase III Trial of SRS for Spinal Metastases
• Phase III Prostate Brachy ± External Beam
• Randomized Phase II Trial Adaptive RT NSCLC
• SBRT vs Surgery for Early Stage NSCLC
• Rand Phase II Hypofractionated RT Prostate
Cancer
• Hippocampal Sparing Whole Brain RT
-
Hippocampus Delineation by Software
-
Hippocampus Avoidance with IMRT
30 Gy
6 Gy
3 GY
Avoidance Region
IMRT can achieve significant RT dosereduction (hippocampus), while delivering 30 Gy to the rest of the brain
-
RTOG 0236:
• First cooperative group SBRT trial for patients with medically inoperable stage I NSCLC.
• 20 Gy times 3 fractions = 60 Gy
Stereotactic Body Radiation Therapy
Pulmonary VeinPulmonary VeinBronchusBronchus
EsophagusEsophagus
CordCord SkinSkin
ChestwallChestwall
LungLung
Physical Targeting
-
• First North American cooperative group trial testing SBRT
• Non-small cell lung cancer - biopsy proven
• T1, T2 (≤≤≤≤ 5 cm) and T3 (chest wall only, ≤≤≤≤ 5 cm), N0, M0
• Medical problems precluding surgery(e.g. emphysema, heart disease, diabetes)
• No other planned therapy
Robert Timmerman, MD; Rebecca Paulus,
BS; James Galvin, PhD; Jeffrey Michalski, MD; William Straube, PhD; Jeffrey Bradley,
MD; Achilles Fakiris, MD; Andrea Bezjak,
MD; Gregory Videtic, MD;David Johnstone, MD; Jack Fowler, PhD; Elizabeth Gore, MD; Hak Choy, MD
:RTOG 0236
-
Lo
ca
l C
on
tro
l (%
)
0
25
50
75
100
Months after Start of SBRT
0 6 12 18 24 30 360
25
50
75
100
0 6 12 18 24 30 36
Patientsat Risk 55 54 47 46 39 34 23
Fail: 1Total: 55
/ / / / / /// / / // /// / / / / / // / // //// //
Local Tumor Control Rate: RTOG 0236
• 1 failure within PTV, 0 within 1 cm of PTV
36 monthlocal control = 98% (CI: 84-100%)
-
Physical Targeting with SBRT:
• RTOG 0618: SBRT for Operable Stage I NSCLC
• RTOG 0813: SBRT for Central Early Stage NSCLC
0
20
40
60
80
100
0 20 40 60 80
Total Dose (Gy) in 3 Fractions
Current and Planned Trials
-
Phase III Study of Sublobar Resection versus
SBRT in High Risk Patients with Stage I NSCLC
Z4099 / R1021
-
Physical Targeting
Toxicity Reduction Endpoints
• Anal Cancer IMRT Trial
• Rectal Cancer IMRT Trial
• Nasopharyngeal Cancer IMRT Trial
• Cervix/Endometrial Cancer IMRT Trial
Toxicity Reduction Endpoints
-
Physical Targeting
Enhanced Tumor Control Endpoints
• Stereotactic Radiation NSCLC
• Higher Dose RT
– NSCLC
– Prostate Cancer
– SCLC
• Concomitant Boost RT in H&N Cancer
-
Future Initiatives
Physical Targeting
• Greater Integration with Other Research Themes
– Use of Biomarkers in Defining Physical Targeting
– Use of Patient-Reported Outcomes in Assessing
Therapy
• Expansion of Anatomic Atlases
• Initiative with ACRIN on Brain Tumors
-
Research Initiatives & Strategic Themes
• Physical Targeting
• Molecular Targeting with RT or ChemoRT
• Translational and Analytic Research
-
Novel Agents with RT / ChemoRT
• RTOG will design and conduct hypothesis-driven trials testing the integration of new classes of molecular targeted anti-cancer agents with optimized RT or chemo-RT.
-
RTOG Landmark Trials of Systemic Therapies
• Cervix Cancer
• Localized/Locally Advanced Prostate Cancer
• Stage III NSCLC
• Head and Neck Cancer
• GI Cancer (Anal, Esophageal, & Pancreatic)
• Brain Tumors
Builds on RTOG-Generated Level 1 Evidence
for Combined Modality Therapy
-
Recent Selected RTOG Landmark Trials
• Role of Gemcitabine in Pancreatic Cancer (JAMA 2008)
• Optimal ChemoRT for Anal Cancer (JAMA 2008)
• ChemoRT for High Risk Resected H&N Cancer (NEJM 2004)
• Role of Surgery in N2 NSCLC (Lancet 2010)
• Role of Chemo in Anaplastic Gliomas (JCO 2006, NEJM Submission 2012)
• Value of Long Term Androgen Suppression in Locally Advanced Prostate Cancer (JCO 2008)
• Concurrent vs Sequential Chemo-RT in Stage III NSCLC (JNCI 2011)
• Androgen Derivation in Early Stage Prostate Cancer (NEJM 2011)
Combined Modality Testing
-
Criteria for Selecting Agents for Testing
• Scientific Rationale
• Pre-Clinical Synergism with RT (CURE Funding)
• Antitumor “Activity” without RT in Given Disease
• Meaningful Opportunity to Improve Tumor Control
• Low Likelihood of High Toxicity
• Availability of Agent for Testing
• Use Optimized RT
-
Biomarker-Based Clinical Trials
• Adult Malignant Glioma (Grade 3 & 4)
– Glioblastoma Multiforme
– Anaplastic Astrocytoma
– Anaplastic Oligodendroglioma
-
Malignant Glioma Trial History
• Pre-1994: All in Same Trials: Stratified by Grade
• 1993: Malignant Glioma RPA, JNCI
• 1994: 3 Patient Category Trials
Glioblastoma Multiforme
Anaplastic Astrocytoma
Anaplastic Oliogodendroglioma
-
RTOG Pt Classes by Recursive Partitioning Analysis of Prognostic Factors
Median Survival 2-Year
Class Characteristics (Months) Survival
I AAF, 50 yr, KPS 70-100, >3 mo time to first symptom 37.4 68
III AAF, 50 yr, KPS
70-100 biopsy only, received >54.4 Gy; or >50 yr, KPS 50 yr, KPS 70-100, biopsy only received 50 yr, KPS
-
Age• < 50• ≥ 50
KPS• 60-70• ≥ 80
Anaplasia• Moderate• High
Anaplastic Astro/Oligo: RTOG 9402
N = 292 to detect 50% relative improvement in median survival time
Molecular Targeting and Combined Modalities
1p19q analysis: 1p19q codeleted vs. one or neither deleted
RANDOMIZE
RANDOMIZE
STRATIFY
STRATIFY
Eligibility Confirmed by Central Path Review
RTRT
Arm 2: RT Only
Arm 1:I-PCV x 4 cycles (q 6 wks) followed by RT
RTRT
PCVPCV PCVPCV PCVPCV PCVPCV
-
RTOG 9402 – Chromosomes 1p, 19q DataAnaplastic Astro/Oligo
-
RTOG 9402: Long-term Results
• Co-Deleted Patients have Longer Survival with Chemo-RT than RT Alone
• Submitted to NEJM Feb 2012
0
25
50
75
100
00 11 22 33 44 55 66 77 88 99 1010
Cumulative RelapseCumulative Relapse
RT
ChemoRT
Codeleted Patients
Years from Randomization
% C
um
ula
tive
In
cid
en
ce
of
Pro
gre
ss
ion
0
25
50
75
100
0 1 2 3 4 5 6 7 8 9 10
Overall Survival
1p19q del
Non codeleted
Years from Randomization
% A
live
-
TMZ daily x 6 wks
RT 60 Gy (2 Gy 5 d per wk)
Concurrent Phase Adjuvant Phase (12 mos)
Tissue Collection Tissue Collection
& Evaluation& Evaluation
RTOG/EORTC 0525: GBM Schema
N = 1153 to detect 25% relative improvement in median survival
Arm 1: TMZ d 1-5 x 6 cycles
Arm 2: TMZ d 1-21 x 6 cycles
RR
EE
GG
II
SS
TT
EE
RR Stratify Stratify •• MGMT StatusMGMT Status
•• RPA ClassRPA Class
•• RT PlanRT Plan
TMZ daily
TM
Z d
ail
y
TM
Z d
ail
y
TMZ daily
RR
AA
NN
DD
OO
MM
II
ZZ
EE
-
Comprehensive RTOG Glioma Trials
New Ph I, II, III portfolio
rRT +new agentsRTAntiangiogenic agents No AAOther signaling inhibitorsYes AA
Low
riskHi risk
Observation: NCF/QOL
RT/TMZ/PARP InhibitorClinical
Low risk
Hi risk
RT vs. TMZ vs. RT/TMZ
RT vs CRT (+/- A TMZ)
Molecular
e.g. Wafers/EGFR vaccineS
Rec
TISSUE
G2
G3
G4
-
GBM: Molecular Targeting
RT (30 Gy) TMZ (75 mg/m2 /d)
ARM A30 Gy + Daily TMZ
(75 mg/m2 qd) + placebo q 2 wks
TMZ (150 - 200 mg/m2)d 1-5 q28d X 12 C+ placebo q 2 wks
Phase III Bevacuzimab (RTOG 0825)
ARM B30 Gy + Daily TMZ
(75 mg/m2 qd) + Bev (10 mg/m2 q 2 wks)
TMZ (150 - 200 mg/m2)
d 1-5 q28d X 12 C + Bev (10 mg/m2 q 2 wks)
EligibleEligible•• GBMGBM•• KPS KPS ≥≥≥≥≥≥≥≥ 7070
•• Age Age ≥≥≥≥≥≥≥≥ 1818•• Tissue +Tissue +
MGMT & Molecular
Profile Analysis
RR
AA
NN
DD
OO
MM
II
ZZ
EE
Stratify Stratify •• RPA RPA
Class Class
•• MGMT MGMT
StatusStatus
•• MoleculMolecul
ar ar
ProfileProfile
Concurrent Phase
Adjuvant Phase
RR
EE
GG
II
SS
TT
EE
RR
-
GBM Biology
Combining RPA and
Molecular Data to
develop molecular-
clinical predictor in
validation set:
RTOG 0525
Clinical
(RPA)
Molecular
only
Molecular + clinical
(MCP)
-
Future Plans: Molecular Targeting
Recurrent GBM Trials/Concepts
Class Agent Study Mol Selection
PanTKIs Dasatanib 0627 P: SRC, c-kit, PDGFR, Eph2
Angiogenesis Bevacuzimab 0625 R: Gene Profile
Angiogenesis Cedarinib +
Sorafenib
Dev R: Gene Profile, Plasma
markers
Anti-EGFR EGFRvIII 0824 P: EGFRvIII
Anti-PARP I ABT 888 Dev R: PARP-1
Anti-mTor RAD 001 Dev Retrospective: PI3K, pAKT
-
RTOG Research Initiatives & Strategic Themes
• Physical Targeting
• Molecular Targeting with RT or ChemoRT
• Translational and Analytic Research
-
Translational and Analytic Research
• The RTOG has unique and inter-linked clinical, biophysical, biologic, and outcomes
databases.
• RTOG will develop and implement powerful biostatistical and medical informatics
approaches that will facilitate hypothesis-
driven analyses of these resources.
-
Selected Achievements
• Addition of Biomarkers to RTOG Brain Tumor RPA (IJROBP 2005)
• New Adverse Event System for H&N Cancer (Lancet Oncology
2007)
• New RTOG/ASTRO PSA Failure Definition (IJROBP 2006)
• Economic Analysis of RTOG H&N Cancer Trial Using CMS (PASCO 2006)
• HPV in Oropharyngeal Cancer (NEJM 2011)
• Published Biomarker Analysis in Most Disease Sites
Translational and Analytic Research
-
RTOG 0129: Objective & Study Design
Test relative efficacy of combining accelerated fractionation (AFX-C) or standard fractionation (SFX)
with cisplatin for the treatment of LA-HNSCC
Stage III & IV* SCC of:• Oral cavity
• Oropharynx
• Larynx
• Hypopharynx
Stratify :• Lx vs Non-Lx
• No vs N+
• KPS 60-80 VS 90-100
R
A
N
D
O
M
IZ
E
1. AFX-CB: 72 Gy/42 F/6 W + CDDP: 100 mg/m2, q3W x 2
2.2. SFX: 70 Gy/35 F/7 W +CDDP: 100 mg/m2, q3W x 3
Excluded T1N+, T2N1
1°endpoint: overall survivalSample size: 720 patients to detect 25% reduction in the death rate (80% power)
-
HPV Status Analysis Methods
� HPV16 in situ hybridization (ISH)
� HPV16 negative – wide spectrum ISH
(HPV 18, 31, 33, 35, 39, 45, 52, 56, 59, 68)
� P16 immunohistochemistry
Laboratory methodology
Statistical analysis� OS – randomization to death
� PFS- randomization to progression or death
� Kaplan-Meier compared by log-rank
� Cox proportional hazards models
-
RTOG 0129: Results of HPV Analysis
P16-positive P16-negative
HPV-positive 192 (96%) 7 (4%)
HPV-negative 22 (19%) 94 (81%)
� 433 (60%) of 721 had oropharynx primary� 323 (75%) of 433 had HPV determination� 206 (64%) of 323 were HPV-positive� 198 (96%) of 206 were HPV16-positive
Kappa = 0.80: 95%CI 0.73-0.87
-
Overall Survival by HPV StatusAng and Gillison et al., NEJM 2010
log-rank p
-
HPV Findings and Conclusions
� Tumor HPV status is a strong and independent predictor of OS and PFS for patients with oropharynx cancer.
� Rates for local-regional, but not distant, recurrence events were lower for the HPV-positive patient.
� Tobacco use appears to modify the biological behavior of an HPV-positive tumor.
� Tumor HPV status must be a stratification factor in clinical trials that include oropharynx patients..
-
Overall Prognosis: HPV
Oropharyngeal Ca
HPV-positive HPV-negative
≤ 10 pack-years > 10 pack-years≤ 10 pack-years> 10 pack-years
T2-3N2b-3N0-2a T4
Low-risk
Intermediate-risk
High-risk
-
HPV Status Clinical Trial Implications
�Partitioning of Oropharyngeal Cancer Pts into 3 Risk Groups Based on HPV and Smoking Status:
�Low-Risk: HPV+, Little Tobacco Use�Goal: Maintain Tumor Control, Less Toxicity
�High-Risk: HPV-, More Tobacco Use�Goal: Improve Tumor Control, Intensify Therapy
�Intermediate Risk: HPV+, More Tobacco UseHPV-, Less Tobacco Use
-
RTOG Phase III Trial 1016 for
HPV-Positive Oropharyngeal Cancer Pts
HPV+ Oropharyngeal Cancer
RANDOMIZE
Radiotherapy weeks 1-6
+
Cisplatin 100 mg/m2 d 1,22
Cetuximab 400 mg/m2 d1, then
250 mg/m2 weeks 2-8
+
Radiotherapy weeks 2-7
n=500+
-
HPV Negative Pt Strategy
�Require Treatment Escalation Rather than De-Escalation
�RTOG-Led Proposal at Testing Lapatinib with Chemo-RT
�No Current Phase III Question
-
Patients at RiskQuartile 1-3Quartile 4
Patients at Risk22875
Patients at Risk12432
Patients at Risk9020
Patients at Risk7615
Patients at Risk6612
Patients at Risk6111
Failed / Total51 / 228 27 / 75
Hazard Ratio (95% CI):2.106 (1.318, 3.365)
Quartile 1-3Quartile 4
Meta
sta
ses (
%)
0
25
50
75
100
Years after Randomization
0 1 2 3 4 5
AQUA nLox & Time to Metastasis in RTOG 9003
Lower nLox Expression
Higher nLox Expression
-
A National Cancer
Clinical Trials System
for the 21st Century:
Reinvigorating the NCI
Cooperative Group Program
Committee on Cancer Clinical Trials and the
NCI Cooperative Group Program
Board on Health Care Services
Consensus
April 15, 2010
-
� New RFA for an Integrated National Clinical Trials Network (NCTN)
� Consolidated Organizational Structure with Funding for 1
Pediatric Group and up to 4 Adult Groups
� Funding Model with Increased Per-Case Reimbursement for
“High-Performance” Academic & Community Sites
� Competitive Integrated Translational Science Awards
� Revitalize Cancer Center Role in the Network (U10 awards)
NCI Proposal for Transforming the System
-
Jan 2014
-
Network
Component
Mechanism
(Duration)
Est. Max.
# Grants
Frequency
New Application
Accepted?
Multiple PI
Option?
Group Operations Centers U10 (5 Yrs) 5 Every 5 Years Yes
Group Statistical & Data Mgt
Centers
U10 (5 Yrs) 5 Every 5 Years Yes
Canadian Collaborating
Network
U10 (5 Yrs) 1 Every 5 Years Yes
Integrated Translational
Science Awards
U10 (5 Yrs) 1 to 5 Every 5 Years Yes
RT and Imaging
Core Services
U24 (5 Yrs) 1 to 2 Every 5 Years Yes
Lead Academic
Participating Sites
U10 (5 Yrs) 30 to 40 Any Year Yes
Overview of RFA: Cooperative Agreement FOAs and
Estimated # Grants
-
Three Venerable Acronyms
Fade Away As Cooperative
Groups Form "Alliance"
News ReleaseJune 17, 2011
ACOSOG CALGB
ALLIANCE
-
Clinical Research:
ECOG to Absorb ACRIN
Cancer Programs;
Goal of Four Groups Is One Merger Away
March 18, 2011
-
Oct. 21, 2011
The Number of Adult Groups Drops to
Four As NSABP, RTOG and GOG
Agree To Merge
MOU signed Oct 19, 2011
-
Proposed Name of Group 4
NRG Oncology*
“Energy Oncology”
*Subject to legal inquiry and registering with the U.S. Patent and
Trademark Office
-
RTOG within NRG OncologyChallenges
• Caloric Expenditure in Merger Effort
• Challenges of Prioritization
• Avoiding Duplication vs Maintaining Identity
• RTOG Volunteerism: How to Continue?
• Membership/Engagement at Institutional Level?
• Rad Onc Career Development within RTOG?
• Future Identity within NCTN
-
RTOG within NRG OncologyOpportunities
• Most Unique of 4 Adult Cooperative Groups
• Potential for Higher Level of NCI Support
• Expertise in Contracting w Industry in NSABP
• Phase I/II Expertise in GOG
• Selection of “Best Processes” across the Group
• Strengthening of Breast, Gyn, and GI Cancer
Research via Committee Mergers
-
RTOG Next Generation Investigators
-
RTOG Future Trials
•Proposed Transition will be Most Significant in Group’s History
•Challenges & Opportunities Abound
•Engagement of Leaders within Radiation Oncology Research in this Process is Critical
-
Opportunities for Advocacy?
•Increased Financial Support for Groups!
•Greater Flexibility regarding Coop Groups
–Ex, Tumor Banks
•Greater Financial Support for Groups
-
Trials Program Funding 2000 to 2011: Real $
-
5-Year Annual Funding Request for
NCI Clinical Trials Network
Category for Base Division Set-Aside
for Network Program
Annual Total Cost for FY14 to FY18Based on 20% Reduction in Accrual Compared
to Average Accrual Over Last 6 Years
(Approx. 20,000 Treatment Trial Enrollments)
Funding Based on FY2011 Levels:
$ 152,644,335 Group Operations & Statistical Centers
(includes Capitation), Lead Academic Participating Sites,
and Core Services
Funding Request Based on New Funding Model & BIQSFP:
$ 11,520,000 Increase Capitation to "High-Performance" DCTD-funded Sites
Increase Capitation to "High-Performance”DCP-funded CCOPs & MB-CCOPs
$ 10,080,000
Increase Funding for Integral and Integrated Markers (BIQSPF)
$ 4,000,000
Subtotal: $ 25,600,000
Grand Total: $ 178,244,335 *
* The 5-Year Total Cost Funding Request for FY2014 to FY2018 for the NCTN is $891,221,675
-
Opportunities for Advocacy?
•Politically Under-Ambitious Vision
•Let’s Decrease Clinical Trial Enrollment!?
•Shameful Decline in Support for Clinical Cancer Research
•Risk of Decline in Clinical Trial Engagement of ACRO Members.