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Current Protocols of the Radiation Therapy Oncology Group

Current Protocols of the Radiation Therapy Oncology Group. Montreal, Quebec Nov. 12, 2004. Phase II Trial (RTOG S-0132): Study Design. R E S E C T I O N. Adjuvant imatinib mesylate (600 mg/d, PO 2 y). SD/PR. Resectable GIST (candidate for neoadjuvant therapy).

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Current Protocols of the Radiation Therapy Oncology Group

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  1. Current Protocols of the Radiation Therapy Oncology Group Montreal, Quebec Nov. 12, 2004

  2. Phase II Trial (RTOG S-0132):Study Design R E S E C T I O N Adjuvant imatinib mesylate (600 mg/d, PO 2 y) SD/PR Resectable GIST (candidate for neoadjuvanttherapy) Neoadjuvantimatinib mesylate (600 mg/d, 8 wk) FollowforPFS R E S E C T I O N PD Off study

  3. Phase II Trial (RTOG S-0132):Eligibility Potentially resectable primary tumors > 5cm Potentially resectable metastatic tumors > 2 cm C-Kitt expression must be documented

  4. Phase II Trial (RTOG S-0132):Study Design* (Cont’d) Objectives: Primary: PFS with imatinib mesylate in adjuvant setting Secondary: Response rate in neoadjuvant setting Compare CT and PET responses in neoadjuvant setting Safety in adjuvant setting Treatment: Imatinib mesylate 600 mg/d Inclusion: Present with KIT-positive malignant GIST No extra-abdominal disease Imatinib mesylate–naive No prior therapy 28 days before entry *Trial ongoing.

  5. RTOG 0132 Biological Correlates Before and After Gleevec: A. Fixed Tissue • KIT mutational analysis • Glut 4 expression correlation with PET SUV B. Frozen Tissue - Global genomic array to evaluate differential gene expression before and after Gleevec - Evaluation of phosphorylation of intermediate signaling molecules within the KIT activation pathway

  6. RTOG 0132: Status of Protocol • Protocol opened February 28, 2002 • Accrual goal is 65 patients • Accrual as of Oct. 26, 2004 is 35 patients

  7. A Pilot Phase II Study Of Pre-operative Radiation Therapy And Thalidomide For Low Grade Primary Soft Tissue Sarcoma Or Pre-operative Maid/thalidomide/radiation Therapy For High/intermediate Grade Primary Soft Tissue Sarcoma Of The Extremity Or Body Wall RTOG 0330

  8. Rationale for Thalidomide • immunomodulatory agent • antiangiogenic properties • potential relationship to circulating levels of bFGF and VEGF • these appear to be elevated in patients with STS • frequently used in combination therapy • well tolerated • oral agent

  9. RTOG 0330: Eligibility for Cohort A • Cohort A : tumor > 8.0 cm in maximal diameter and intermediate to high grade • Normal heart function (EF ≥ 50%) • Accrual goal is 22 patients

  10. RTOG 0330: Cohort A • based upon experience with RTOG 9514 additional new questions/endpoints • toxicity issues of 9514 & with Thalidomide • benefit of addition of agent with alternative mechanism of action • biologic endpoints • response (clinical response & necrosis on central pathology review)

  11. RTOG 0330: Cohort A Biopsy & submission to central pathology, Blood draws x 6 RT: 22 Gy/course, 44 Gy total Thalidomide 200 mg/day for 1 year Thalidomide Surgery Day 80 RT RT MAID MAID MAID MAID Diagnosis & Registration RT: 16 Gy for + margins Accrual goal 22 patients

  12. RTOG 0330: Translational Studies(an Abbreviated List) Paraffin Blocks from Biopsy and Resections • Microvessel Density • Biological /Prognostic Markers • uPA/ tPA/ PAI-1 • EGFR, p53, Ki-67,Tunel Studies on Circulating Factors Using WB • VEGF and bFGF • Circulating endothelial cells (CEC)

  13. RTOG 0330: Eligibility Cohort B • Low grade STS (Grade 1 or 2) and > 5 cm in diameter in greatest dimension. • Accrual goal is 22 patients.

  14. RTOG 0330: Cohort B RT 50 Gy in 5 weeks Surgery Thalidomide 200mg/day Thalidomide 200mg/day for 6 months 22 patients

  15. RTOG 0330: Translational Studies(an Abbreviated List) Paraffin Blocks from Biopsy and Resections • Microvessel Density • Biological /Prognostic Markers • uPA/ tPA/ PAI-1 • EGFR, p53, Ki-67,Tunel Studies on Circulating Factors Using WB • VEGF and bFGF • Circulating endothelial cells (CEC)

  16. RTOG 0330: Status • CTEP Approved and open for 3 months • Open at 5 centers • No patients accrued

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