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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04288375
• Other study ID #: 20-064
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2020
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Kaled Alektiar, MD
• Phone: 212-639-7981
• Email: alektiak[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All protocol activities)	Basking Ridge	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 Monmouth (All protocol activities)	Middletown	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 Nassau (All protocol activities)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival	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	2 years

External Links

•   Memorial Sloan Kettering Cancer Center