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Robert S. Benjamin, M.D.

SARC018: A SARC PILOT MULTICENTER STUDY OF PREOPERATIVE RADIATION AND SURGERY IN PATIENTS WITH HIGH-RISK DESMOID TUMORS. Robert S. Benjamin, M.D. Objectives.

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Robert S. Benjamin, M.D.

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  1. SARC018: A SARC PILOT MULTICENTER STUDY OF PREOPERATIVE RADIATION AND SURGERY IN PATIENTS WITH HIGH-RISK DESMOID TUMORS Robert S. Benjamin, M.D.

  2. Objectives • The trial’s primary objectives are to determine feasibility of performing a multicenter study of radiation therapy through SARC and to determine overall progression-free survival from start of treatment in these patients.

  3. Background • Patients with desmoid fibromatosis and 45F beta catenin mutation (28% in our series) who underwent surgical resection as initial therapy at our institution have a 45% 3- or 5-year recurrence-free survival compared with about 80% for those with 41A mutation or no detectable mutation.

  4. Background (continued) • Radiation therapy has been effective in the treatment of desmoid patients with a similar degree of local control as surgery. • Of the 7 patients received radiotherapy in combination with surgery, 2 (28%) experienced tumor recurrence within the follow up period, in contrast with 21/27 patients (77%) who have not been treated with radiation.

  5. Screening • Slides for diagnosis and unstained slides or blocks for DNA extraction should be sent to Dr. Dina Lev at M.D. Anderson. • Patients with 45F beta catenin mutation would be considered for the protocol.

  6. Eligibility • Desmoid tumor with 45 F beta catenin mutation and no FAP mutation. • Tumor must be • Resectable • <25 cm in largest dimension • Location such that radiation can be delivered with acceptable normal tissue toxicity • In an region that has not been previously irradiated

  7. Pretreatment Evaluation • MRI with and without contrast should be obtained on each patient. • The post-contrast T1 image will be used for radiation planning.

  8. Radiation Therapy • Either 3D conformal radiation therapy or intensity modulated radiation therapy or electron radiotherapy may be utilized as deemed appropriate. • A prescription dose of 50 Gy in 25 daily fractions will be prescribed.

  9. Surgery • Wide resection of the tumor will be performed 4-8 weeks following completion of radiation therapy.

  10. Follow-up • In addition to physical examination, CT, MRI, or Ultrasound will be performed on the following schedule: • Years 1-3: Every 4 months • Years 4-5: Every 6 months • Years 6-10: Every 12 months

  11. Radiation Therapy Quality Assurance • Radiation treatment planning records will be sent to Dr. Ashleigh Guadagnolo at M.D. Anderson for review. • If any portion of the gross target volume (GTV) receives <50 Gy, that is a major protocol violation. • If any portion of the clinical target volume (CTV) receives <50 Gy, that is a minor protocol violation.

  12. Statistical Considerations • This is a pilot study to determine if a larger study could be performed and is of clinical interest. • Major protocol violations should not exceed 3 patients (10%). • A median progression-free survival of >4.5 years would be of interest, while a median progression-free survival of 2.6 years would not warrant further study.

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