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RTOG1106: Randomized Phase IIR Trial of Personalized Adaptive Radiotherapy Based on Mid-treatment FDG-PET in Locally Adv PowerPoint Presentation
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RTOG1106: Randomized Phase IIR Trial of Personalized Adaptive Radiotherapy Based on Mid-treatment FDG-PET in Locally Advanced NSCLC. P.I.: Feng-Ming (Spring) Kong, M.D., Ph.D. Study Team Mitchell Machtay, M.D. Jeffrey D. Bradley, M.D. Jean Moran, Ph.D. Vera Hirsh, M.D. Barry Siegel, M.D.

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slide1

RTOG1106: Randomized Phase IIR Trial of Personalized Adaptive Radiotherapy Based on Mid-treatment FDG-PET in Locally Advanced NSCLC

P.I.: Feng-Ming (Spring) Kong, M.D., Ph.D.

Study Team

Mitchell Machtay, M.D.

Jeffrey D. Bradley, M.D.

Jean Moran, Ph.D.

Vera Hirsh, M.D.

Barry Siegel, M.D.

rtog 1106 acrinxxxx
RTOG 1106/ACRINxxxx

RTOG

0617 arm:

Standard dose script

Study arm:

Individualadaptive RT

Estimated Sample size: ~120 patients

(85% power to detect 20% difference in 2-yr. local PFS)

slide3

Background - 1

The Traditional Approach

CT

1-3 months

PET

Treatment including

Radiation Therapy

post-treatment

outcome

Weeks to months

Months to years

acrin 6668 rtog 0235 fdg pet
ACRIN 6668/RTOG 0235: FDG-PET

2-3 months after XRT

REGISTER

Eligibility

Stage III NSCLC plan for conc. chemo-RT

PS 0-1

Chemo-RT +/- ‘adjuvant’ chemo

FDG-PET with SUV

FDG-PET with SUV

Primary Endpoint: Survival as a function of post-RT SUV

Sample Size: 250

acrin 6668 rtog 0235 update
ACRIN 6668/RTOG 0235 Update
  • Activation Date: 3/1/2005.
  • Closed to Accrual: 5/15/2009.
  • Total Accrual: 251 pts.
    • 236 verified eligible (94%).
  • Total # Participating Sites: 37.
  • Central Review in Process.
    • Qualitative, SUVpeak, MTV
  • Primary Outcome Analysis in Early/mid 2011.
rtog 0515 results
RTOG 0515 Results

Exploratory trial of pre-Tx FDG-PET for XRT planning

N=47

Bradley et al. ASTRO 2009

hypotheses
Hypotheses
  • Use of mid-treatment FDG-PET is as useful or more useful than pre-RT FDG-PET and/or 3-month post-RT PET.
  • Mid treatment PET can be used to individualize (and escalate) XRT dose will result in improved outcomes (2-yr. LPFS) compared with standard XRT.
slide8

When should PET be done?

The Traditional Approach

CT

1-3 months

PET

  • Post-RT PET response is highly correlated with pathologic response.
  • Post-RT PET is predictive of long term survival and pattern of failure
  • (Mac Manus et al, 2003)
  • RTOG235/Acrin688 results awaited.

Treatment including

Radiation Therapy

post-treatment

outcome

However, post-RT PET tumor response does not provide

an opportunity to change the treatment plan.

Weeks to months

Months to years

pet during rt
PET during RT?
  • PET scan can be performed during-RT
    • University of Michigan study, ASTRO 2005
    • MAASTRO study, ASTRO 2005
    • Stanford study, ASTRO 2007
    • Princess Margaret Hospital, ASTRO 2008
  • UM has demonstrated that PET response at 45 Gy during-RT was highly correlated with post-RT response in a small pilot study.
  • The above finding has been recently validated in another 50+ patients from Michigan.

Kong et al, JCO, 2007

individualized rt escalation is feasible
Individualized RT Escalation Is Feasible

Michigan trial usees PET-MTV guided isotoxicity adaptive plan to escalate tumor dose:

30 daily treatments, 2.2-3.8 Gy per fraction, 66 Gy~85.5 Gy

To NTCP of 17% (mean lung dose 20 Gy), with concurrent and adjuvant carbo and taxol, maximum at102 Gy in 2 Gy equivalent dose for lung (=ED2) (92 Gy ED2 for tumor).

14 patients completed treatments per study, all patients treated >74 Gy ED2 (median=92 Gy for tumor), majority of them received the maximum dose.

6 patients followed up for 1.5 years, no local failure thus far, 2 brain mets, only 1 death thus far from GI bleeding (gastric and esophageal ulcers).

tumor response during rt
Tumor Response During-RT

Tumor

Pre- RT

Tumor

Heart

During-RT at 45 Gy

Tumor

Tumor

Heart

Example-1

slide12

CT-lunGwindow

CT-mediastinum window

UM002

FDGPET

Pre-RT

GTV: 468 cm3

MTV: 353 cm3

During-RT

GTV: 402 cm3

MTV: 268 cm3

3 mo post

GTV: 174 cm3

MTV: 12 cm3

This 48 YO male received 85.5 Gy

(120 Gy BED) had grade 0 clinical toxicity thus far.

He works full time now with heavy duty.

9 mo post

16 mo post

Patient-2

slide13

FDG Activity & PET-MTV Reduction

PET results during RT correlates well with post-RT results

pet mtv decreased more than ct gtv
PET-MTV Decreased More than CT-GTV

50 pts 88 tumors

CT

PET

During-RT

Pre-RT

During-RT

mid course fdg pet and pfs
Mid-course FDG-PET and PFS

1 Year Progression-Free Survival

(Kong et al, ASTRO 2009)

mid course fdg pet and survival
Mid-course FDG-PET and Survival

Local Progression Free Survival

Overall Survival

NSUV During-RT < 3.0

NSUV During-RT < 3.0

NSUV During-RT > 3.0

NSUV During-RT > 3.0

NSUV=tumor SUVmax/Aorta SUVmean.

(Kong et al, ASTRO 2009)

proposed rtog acrin trial
Proposed RTOG/ACRIN Trial
  • Followup to ACRIN 6668/RTOG 0235.
  • FDG-PET during RT
    • Validate UM results
    • Study adaptive RT/dose escalation
    • Randomization to assess the efficacy of mid-treatment FDG-PET
  • Opportunity to study a novel tracer (e.g. F-Miso) in limited institution sub-study.
rtog 1106 acrinxxxx18
RTOG 1106/ACRINxxxx

RTOG

0617 arm:

Standard dose script

Study arm:

Individualadaptive RT

Estimated Sample size: ~120 patients

(85% power to detect 20% difference in 2-yr. local PFS)

secondary aims
Secondary Aims
  • To compare toxicity between such a PET image-guided adaptive dose escalation and conventional RT.
  • To validate recent findings from a single institution that a tumor metabolic response during-RT predicts long term local tumor control, LPFS and overall survival.
  • To perform a pilot study to assess whether a novel PET tracer (F-Miso) is more predictive than FDG-PET.
  • To obtain blood and tissue samples to explore relationships between imaging findings, biomarkers and outcomes (both anti-tumor efficacy and toxicity).
flt versus f miso
FLT versus F-Miso

Which is the ‘better’ exploratory agent?

other issues still to be resolved
Other Issues Still to be Resolved
  • ACRIN Co-PI TBA.
  • Radiotherapy Fractionation issues.
  • Randomization, stratification issues.
  • Sample size for FLT/FMISO sub-study.
  • Insurance company reimbursement for mid course PET.