Status:
RECRUITING
Dose Reduction of Postoperative Radiation for Soft Tissue Sarcoma of the Arms and Legs
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigators are doing this study to find out whether lowering the dose of postoperative radiation therapy and targeting a smaller area of tissue for treatment is as effective as the standard dos...
Eligibility Criteria
Inclusion
- Patients must be diagnosed with a primary soft tissue sarcoma of the extremity, confirmed by MSKCC pathologic review
- Age at the time of enrollment of ≥18 years
- Patients must have undergone margin-negative oncologic resection of their primary tumor, as confirmed by MSKCC pathologic review
- Patients must be able to start radiation within 3 months from time of surgery
- °If patient is receiving adjuvant chemotherapy, patient must start RT no longer than 3 months past their chemo treatment.
- Female patients of childbearing potential must have a negative serum pregnancy test within 14 days of radiation start (or if urine test, within 24 hours of radiation start)
- Sexually active patients of childbearing potential must agree to use effective contraception.
- The use of chemotherapy will not be dictated by this trial. Patients are allowed to receive chemotherapy at the discretion of the disease management team (as is standard practice to make individualized decisions for each patient regarding the use of chemotherapy).
Exclusion
- Patients with positive margins after surgical resection as indicated by MSKCC pathologic review
- Patients with diagnosis of superficial myxofibrosarcoma with indistinct/infiltrative borders on preoperative MRI16 (see Appendix Figure 1 for reference figure)
- Patients with multifocal disease in the extremity
- Patients who have received prior radiotherapy at or adjacent to the primary tumor bed
- Patients with a differentinvasive cancer requiring active treatment at the time of enrollment.
- Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study
Key Trial Info
Start Date :
February 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04288375
Start Date
February 26 2020
End Date
February 1 2026
Last Update
March 4 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, United States, 11725