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Current RTOG Soft Tissue Sarcoma Trials

Current RTOG Soft Tissue Sarcoma Trials. S-0132 A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase 0330

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Current RTOG Soft Tissue Sarcoma Trials

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  1. Current RTOG Soft Tissue Sarcoma Trials • S-0132 • A Phase II Trial of Neoadjuvant/Adjuvant STI-571 (Gleevec) for Primary and Recurrent Operable Malignant GIST Expressing the KIT Receptor Tyrosine Kinase • 0330 • 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

  2. RTOG S-0132 • baseline PET/CT/core biopsies • Gleevec 600mg/day • repeat PET/CT 1-7 days • repeat PET/CT at 4 and 8 weeks • surgery if not responding or after 8 weeks • Gleevec 600mg/day for 2 years

  3. RTOG S-0132 • opened 2/2002 • accrual target- 63 • accrual to date- 55 • objectives • response rates to Gleevec prior to surgery • recurrence free survival • biologic endpoints (KIT mutational analysis, tumor differences pre/post therapy)

  4. RTOG 0330 • based upon experience with RTOG 9514 but with additional new questions/endpoints • toxicity issues of 9514 • benefit of addition of agent with alternative mechanism of action • biologic endpoints • incorporation of low grade tumors

  5. RTOG 0330: Objectives • local control and disease-free survival • relationship to surrogate biological endpoints • treatment delivery/toxicity of combination treatment utilizing thalidomide • tolerance of long term post-operative adjuvant thalidomide • feasibility of employing specific tissue and circulating biomarkers of antiangiogenic response in a multi-institutional setting • quantitative changes and patient variation in these biomarkers before, during, and after therapy • to develop baseline data sets of biomarkers, particularly circulating endothelial cells, for future study design for combined antiangiogenic therapy

  6. 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

  7. Cohorts for RTOG 0330 Cohort A high/intermediate grade (histologic grade 3 or 4) tumor ≥ 8 cm in greatest dimension Cohort B low grade (histologic grade 1or 2) tumor > 5 cm in greatest dimension

  8. XRT/ THAL XRT/ THAL MAID MAID MAID 12 mos THAL Surgery +/- boost XRT/THAL Cohort A neoadjuvant MAID (Mesna, Doxorubicin, Ifosfamide, DTIC) x 3 cycles, concurrent thalidomide and radiation therapy (XRT) x 2 cycles, followed by surgical resection, followed by adjuvant thalidomide for one year (post-op boost XRT if positive margin) Goal accrual: 22 patients

  9. XRT/ THAL 6 mos THAL Surgery THAL until surgery +/- boost XRT/THAL Cohort B neoadjuvant concurrent thalidomide and XRT (stop thalidomide 1 week prior to surgery), followed by surgical resection, followed by adjuvant thalidomide for 6 months (post-op boost XRT if positive margin) Goal accrual: 22 patients

  10. RTOG 0330 • opened 4/2004 • accrual target- 44 (22 A/ 22 B) • accrual to date- 12 (6 A/ 6 B)

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