Dose Reduction of Postoperative Radiation for Soft Tissue Sarcoma of the Arms and Legs

NCT04288375 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: 20-064
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 7

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 dose and volume of radiation therapy to control soft tissue sarcoma after surgery. They also want to find out whether the study approach causes fewer and less severe long-term side effects than the standard approach.

Conditions

Soft Tissue Sarcoma

Keywords

Postoperative Radiation; Soft Tissue Sarcoma of extremity; 20-064

Outcome Measures

Primary Outcomes (1)

• Assessment of local control at 2 years.

  will be assessed via imaging of the primary tumor site (MRI preferred, CT for patients who cannot get or tolerate an MRI). Imaging must take place at least annually for the first two years post-radiation. Local failure is defined as a relapse in the primary tumor bed.

  2 years

Secondary Outcomes (1)

• overall survival

  2 years

Study Arms (1)

extremity soft tissue sarcoma (STS)

EXPERIMENTAL

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.

Radiation: Intensity-modulated radiation therapy (IMRT)

Interventions

Intensity-modulated radiation therapy (IMRT) RADIATION

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.

extremity soft tissue sarcoma (STS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Sarcoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Kaled Alektiar, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: February 26, 2020
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)