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

Primary Purpose

Soft Tissue Sarcoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intensity-modulated radiation therapy (IMRT)

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring Postoperative Radiation, Soft Tissue Sarcoma of extremity, 20-064

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Basking Ridge (All protocol activities)Recruiting
Memorial Sloan Kettering Monmouth (All protocol activities)Recruiting
Memorial Sloan Kettering Bergen (All protocol activities)Recruiting
Memorial Sloan Kettering Commack (All protocol activities)Recruiting
Memorial Sloan Kettering Westchester (All protocol activities)Recruiting
Memorial Sloan Kettering Cancer CenterRecruiting
Memorial Sloan Kettering Nassau (All protocol activities)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

extremity soft tissue sarcoma (STS)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04288375

First Posted

February 26, 2020

Last Updated

May 1, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT04288375

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 26, 2020 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Soft Tissue Sarcoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

extremity soft tissue sarcoma (STS)

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiation therapy (IMRT)

Intervention Description

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 Outcome Measure Information:

Title

Assessment of local control at 2 years.

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

overall survival

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kaled Alektiar, MD

Phone

212-639-7981

alektiak@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Samuel Singer, MD

Phone

212-639-2164

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Basking Ridge (All protocol activities)

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kalad Alektiar, MD

Phone

212-639-7981

Facility Name

Memorial Sloan Kettering Monmouth (All protocol activities)

City

Middletown

State/Province

New Jersey

ZIP/Postal Code

07748

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD

Phone

212-639-7981

Facility Name

Memorial Sloan Kettering Bergen (All protocol activities)

City

Montvale

State/Province

New Jersey

ZIP/Postal Code

07645

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD, MSc

Phone

212-639-7981

Facility Name

Memorial Sloan Kettering Commack (All protocol activities)

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD

Phone

212-639-7981

Facility Name

Memorial Sloan Kettering Westchester (All protocol activities)

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD

Phone

212-639-7981

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD

Phone

212-639-7981

First Name & Middle Initial & Last Name & Degree

Samuel Singer, MD

Phone

212-639-2164

Facility Name

Memorial Sloan Kettering Nassau (All protocol activities)

City

Uniondale

State/Province

New York

ZIP/Postal Code

11553

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaled Alektiar, MD

Phone

212-639-7981

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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

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