Radiation Therapy
Oncology Group
A Phase II Trial of Accelerated Radiotherapy UsingA Phase II Trial of Accelerated Radioth...
Radiation Therapy
Oncology Group
IntroductionIntroduction
Comprehensive radiotherapeutic strategy
for GBM
SRT boost trial ...
Radiation Therapy
Oncology Group
Study FeaturesStudy Features
Unlike radiosurgery/brachytherapy trials:
- Patients with gr...
Radiation Therapy
Oncology Group
PurposePurpose
To assess the feasibility, toxicity, and
efficacy of four weekly stereotac...
Radiation Therapy
Oncology Group
MethodsMethods
Eligibility Criteria
• Histologically confirmed GBM (gross total
resection...
Radiation Therapy
Oncology Group
RT ScheduleRT Schedule
1 2 3 4 5 6
IIIII IIIII IIII* IIII* IIII* III*
I = standard EBXRT ...
Radiation Therapy
Oncology Group
4 SRT Boosts: weeks 3-64 SRT Boosts: weeks 3-6
GTV: Postoperative residual enhancing lesi...
Radiation Therapy
Oncology Group
SchematicSchematic
Radiation Therapy
Oncology Group
ChemotherapyChemotherapy
BCNU: 80 mg/m2
i.v. for 3 days,
beginning within one month after...
Radiation Therapy
Oncology Group
StatisticsStatistics
A sample size of 76 pts (Dixon-
Simon method) assuming 10%
ineligibi...
Radiation Therapy
Oncology Group
ResultsResults
80 pts enrolled from June, 2001 - June, 2004
4 patients ineligible, 76 ana...
Radiation Therapy
Oncology Group
Overall Survival: 12.5 mos.Overall Survival: 12.5 mos.
RTOG 0023(__) vs. Historical contr...
Radiation Therapy
Oncology GroupOverall Survival – Gross Total ResectionOverall Survival – Gross Total Resection
RTOG 0023...
Radiation Therapy
Oncology Group
ToxicityToxicity
Brain 3 0 1
Skin (within the field) 6 2 0
Eye 2 0 0
Subcutaneous Tissue ...
Radiation Therapy
Oncology Group
Pattern of First FailurePattern of First Failure
in relation to boost volumein relation t...
Radiation Therapy
Oncology Group
Quality AssuranceQuality Assurance
Radiotherapy Review
Per protocol/minor deviation: 90%
...
Radiation Therapy
Oncology Group
ConclusionConclusion
This accelerated, SRT boost trial:
Was feasible
Well tolerated
Resul...
Radiation Therapy
Oncology Group
ThanksThanks
Leading Participating Institutions:
Mass. General Hospital - A. Chakravarti,...
Upcoming SlideShare
Loading in …5
×

Click here to download presentation

236 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
236
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
3
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Click here to download presentation

  1. 1. Radiation Therapy Oncology Group A Phase II Trial of Accelerated Radiotherapy UsingA Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts forWeekly Stereotactic Conformal Boosts for Supratentorial Glioblastoma Multiforme.Supratentorial Glioblastoma Multiforme. RTOG-0023RTOG-0023 Robert Cardinale, M.D. Associate Professor Princeton Medical Center, Princeton, NJ Medical College of Virginia Hospitals, Richmond, VA
  2. 2. Radiation Therapy Oncology Group IntroductionIntroduction Comprehensive radiotherapeutic strategy for GBM SRT boost trial at MCV was well tolerated
  3. 3. Radiation Therapy Oncology Group Study FeaturesStudy Features Unlike radiosurgery/brachytherapy trials: - Patients with gross total resection allowed - Entire resection cavity is included in boost volume - Strict dose homogeneity requirement - Technique uses shaped conformal fields - Large target sizes (post-op diameter up to 60 mm allowed)
  4. 4. Radiation Therapy Oncology Group PurposePurpose To assess the feasibility, toxicity, and efficacy of four weekly stereotactic radiotherapy boosts given during a 50 Gy course of EBXRT for GBM patients
  5. 5. Radiation Therapy Oncology Group MethodsMethods Eligibility Criteria • Histologically confirmed GBM (gross total resection allowed) • Boost GTV < 60 mm • Performance status 0-1, Neurologic function status 0-3 • Adequate bone marrow reserve Ineligibility Criteria • Mutifocal disease • Tumors of the brainstem or within 10 mm of the optic chiasm
  6. 6. Radiation Therapy Oncology Group RT ScheduleRT Schedule 1 2 3 4 5 6 IIIII IIIII IIII* IIII* IIII* III* I = standard EBXRT (pre-op tumor volume plus edema), 2 Gy x 25 fractions * = SRT boost, 5-7 Gy x 4 fractions Week #
  7. 7. Radiation Therapy Oncology Group 4 SRT Boosts: weeks 3-64 SRT Boosts: weeks 3-6 GTV: Postoperative residual enhancing lesion plus entire resection cavity PTV: GTV + 5 mm Dose: Maximum PTV Diameter Dose/fx ≤40 mm 7 Gy >40 mm 5 Gy SRT planning: sites pre- certified, MRI, conformal fields, strict homogeneity requirement
  8. 8. Radiation Therapy Oncology Group SchematicSchematic
  9. 9. Radiation Therapy Oncology Group ChemotherapyChemotherapy BCNU: 80 mg/m2 i.v. for 3 days, beginning within one month after the completion of RT then q 8 weeks for a total of 6 cycles
  10. 10. Radiation Therapy Oncology Group StatisticsStatistics A sample size of 76 pts (Dixon- Simon method) assuming 10% ineligibility rate was used to compare survival with 1027 pts. in the RTOG- RPA class database (p<0.05- one sided)
  11. 11. Radiation Therapy Oncology Group ResultsResults 80 pts enrolled from June, 2001 - June, 2004 4 patients ineligible, 76 analyzed Patient Characteristics: Age (median) 58 Gender (male, female) 63%, 37% Performance Status (0, 1) 64%, 36% Surgery Type Biopsy 24% Subtotal resection 35% Gross total resection 41% RPA Class III 25% IV 50% V 25%
  12. 12. Radiation Therapy Oncology Group Overall Survival: 12.5 mos.Overall Survival: 12.5 mos. RTOG 0023(__) vs. Historical control(---)RTOG 0023(__) vs. Historical control(---) (Same RPA distribution)(Same RPA distribution) %ALIVE 0 25 50 75 100 MONTHS FROM REGISTRATION 0 3 6 9 12 15 18 21 24 / / / / / / / // / // p = 0.5
  13. 13. Radiation Therapy Oncology GroupOverall Survival – Gross Total ResectionOverall Survival – Gross Total Resection RTOG 0023 (__) vs. Historical control (---)RTOG 0023 (__) vs. Historical control (---) %ALIVE 0 25 50 75 100 MONTHS FROM REGISTRATION 0 3 6 9 12 15 18 21 24 / / / / // 17 vs. 12 mos. p= 0.1
  14. 14. Radiation Therapy Oncology Group ToxicityToxicity Brain 3 0 1 Skin (within the field) 6 2 0 Eye 2 0 0 Subcutaneous Tissue 2 0 0 Other 9 1 0 Worst toxicity per patient 9 3 1 Grade (RT late) 1 2 3 (13%) (4%) (1%) Significant toxicity included: one grade 4 acute (lethargy) and one grade 3 late (necrosis). Ten patients experienced grade 4 hematologic toxicity.
  15. 15. Radiation Therapy Oncology Group Pattern of First FailurePattern of First Failure in relation to boost volumein relation to boost volume 65 patients Within target volume 64% Within target volume plus adjacent 25% Adjacent 6% Beyond adjacent 4% Re-operation in 28 patients (43%)
  16. 16. Radiation Therapy Oncology Group Quality AssuranceQuality Assurance Radiotherapy Review Per protocol/minor deviation: 90% Significant deviations: 10% 4 had inadequate target coverage 4 had optic chiasm dose > 55 Gy Chemotherapy Review Per Protocol: 83% Unacceptable Deviation: 1% Incomplete: 17%
  17. 17. Radiation Therapy Oncology Group ConclusionConclusion This accelerated, SRT boost trial: Was feasible Well tolerated Resulted in no significant survival benefit, patients with gross total resection trended toward improved outcome
  18. 18. Radiation Therapy Oncology Group ThanksThanks Leading Participating Institutions: Mass. General Hospital - A. Chakravarti, M.D., Ph.D. Medical College of Wisconsin - A. Choucair, M.D. McGill University - L. Souhami, M.D. Univ. of California, Davis - A. Chen, M.D. Virginia Mason Medical Center - H. Pham, M.D. Mike Gillin, Ph.D. Minesh Mehta, M.D. Minhee Won, M.A. Brian Berkey, M.S. Rupert Schmidt-Ullrich, M.D.

×