RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-26

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04288375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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).	* 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

Inclusion Criteria

Exclusion 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
* 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).

* 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

Contacts and Locations

Study Contact

Kaled Alektiar, MD

CONTACT

212-639-7981

alektiak@mskcc.org

Samuel Singer, MD

CONTACT

212-639-2164

Principal Investigator

Kaled Alektiar, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All protocol activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All protocol activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Kaled Alektiar, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-26

Study Completion Date2025-02

Study Record Updates

Study Start Date2020-02-26

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

Postoperative Radiation
Soft Tissue Sarcoma of extremity
20-064

Additional Relevant MeSH Terms

Soft Tissue Sarcoma