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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extremity soft tissue sarcoma (STS) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-modulated radiation therapy (IMRT) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kaled Alektiar, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All protocol activities) | Basking Ridge | New Jersey | 07920 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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|
| 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 |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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