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Active, Not Recruiting

NCT Number: NCT04288375

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (All protocol activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of local control at 2 years.

    Time frame: 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.

Secondary outcomes

  1. overall survival

    Time frame: 2 years

    will be performed for each patient using clinical data obtained from chart review 2 years after the last patient enrolled is treated. Will use Kaplan Meier methods to estimate survival at 2 years after RT starting at the end of RT

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Reduction of Dose and Volume in Postoperative Radiation for Extremity Soft Tissue Sarcoma

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2020
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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