is multi-center innovative research possible? rtog as a ......median survival 2-year class...

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

• 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




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




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






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.

is multi-center innovative research possible? rtog as a ......median survival 2-year class...

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