Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04288375
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Radiation: Intensity-modulated radiation therapy (IMRT) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of Dose and Volume in Postoperative Radiation for Extremity Soft Tissue Sarcoma
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: extremity soft tissue sarcoma (STS)
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.
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.




Primary Outcome Measures :
  1. Assessment of local control at 2 years. [ Time Frame: 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 :
  1. overall survival [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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) or <70% myxoid component given the distinct failure pattern in these patients14
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04288375


Contacts
Layout table for location contacts
Contact: Kaled Alektiar, MD 212-639-7981 alektiak@mskcc.org
Contact: Samuel Singer, MD 212-639-2164

Locations
Layout table for location information
United States, New Jersey
Memoral Sloan Kettering Basking Ridge (All protocol activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Kalad Alektiar, MD    212-639-7981      
Memoral Sloan Kettering Monmouth (All protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Kaled Alektiar, MD    212-639-7981      
Memorial Sloan Kettering Bergen (All protocol activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Kaled Alektiar, MD, MSc    212-639-7981      
United States, New York
Memorial Sloan Kettering Commack (All protocol activities) Recruiting
Commack, New York, United States, 11725
Contact: Kaled Alektiar, MD    212-639-7981      
Memoral Sloan Kettering Westchester (All protocol activities) Recruiting
Harrison, New York, United States, 10604
Contact: Kaled Alektiar, MD    212-639-7981      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kaled Alektiar, MD    212-639-7981      
Contact: Samuel Singer, MD    212-639-2164      
Memorial Sloan Kettering Nassau (All protocol activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Kaled Alektiar, MD    212-639-7981      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Kaled Alektiar, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04288375    
Other Study ID Numbers: 20-064
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Postoperative Radiation
Soft Tissue Sarcoma of extremity
20-064
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms