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

Phase 2

Recruiting

• Conditions: Soft Tissue Sarcoma
• Interventions: Radiation: Intensity-modulated radiation therapy (IMRT)

• Registration Number: NCT04288375
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-02-26
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
extremity soft tissue sarcoma (STS)	Intensity-modulated radiation therapy (IMRT)	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.

Primary Outcome Measures

Name	Time	Method
Assessment of local control at 2 years.	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 Outcome Measures

Name	Time	Method
overall survival	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Nassau (All protocol activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Westchester (All protocol activities); 🇺🇸 Harrison, New York, United States

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

Memorial Sloan Kettering Bergen (All protocol activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Monmouth (All protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (All protocol activities); 🇺🇸 Commack, New York, United States