Clinical trial NCT04288375: Dose Reduction of Postoperative Radiation for Soft Tissue Sarcoma of the Arms and Legs
Official title: Reduction of Dose and Volume in Postoperative Radiation for Extremity Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Soft Tissue Sarcoma
Keywords: Postoperative Radiation
Soft Tissue Sarcoma of extremity
20-064
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of local control at 2 years.
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (All protocol activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All protocol activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (All protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All protocol activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All protocol activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kaled Alektiar, MD
role: PRINCIPAL_INVESTIGATOR
References: