Dose Reduction of Postoperative Radiation for Soft Tissue Sarcoma of the Arms and Legs
NCT ID: NCT04288375
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2020-02-26
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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extremity soft tissue sarcoma (STS)
Postoperative radiation therapy to the primary site with a reduction in radiation dose and volume. Specifically, the tumor bed plus a margin of 2cm craniocaudally and 1.5cm radially will be utilized to create the clinical target volume. The total dose will consist of 50 Gy in 25 fractions.
Intensity-modulated radiation therapy (IMRT)
The prescribed dose of radiations for all patients will be 50 Gy in 25 fractions. 6MV energy photons will be used. Multi-beam IMRT plans, utilizing dynamic multileaf collimation, will be created based on the target tissue coverage and normal tissue avoidance.
Interventions
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Intensity-modulated radiation therapy (IMRT)
The prescribed dose of radiations for all patients will be 50 Gy in 25 fractions. 6MV energy photons will be used. Multi-beam IMRT plans, utilizing dynamic multileaf collimation, will be created based on the target tissue coverage and normal tissue avoidance.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kaled Alektiar, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All protocol activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (All protocol activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (All protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (All protocol activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (All protocol activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Samuel Singer, MD
Role: CONTACT
Facility Contacts
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Kalad Alektiar, MD
Role: primary
Kaled Alektiar, MD
Role: primary
Kaled Alektiar, MD, MSc
Role: primary
Kaled Alektiar, MD
Role: primary
Kaled Alektiar, MD
Role: primary
Kaled Alektiar, MD
Role: primary
Samuel Singer, MD
Role: backup
Kaled Alektiar, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-064
Identifier Type: -
Identifier Source: org_study_id
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