Lowering radiation dose for soft tissue sarcoma treatment
Reduction of Dose and Volume in Postoperative Radiation for Extremity Soft Tissue Sarcoma
This study is testing if using less radiation in a smaller area after surgery can still effectively control soft tissue sarcoma in the arms and legs while also checking for any long-term side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT04288375 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if reducing the dose and targeting a smaller area of postoperative radiation therapy is as effective as the standard approach for controlling soft tissue sarcoma in the arms and legs. The investigators will assess the effectiveness of intensity-modulated radiation therapy (IMRT) while also evaluating the long-term side effects associated with this reduced treatment. Patients who have undergone successful surgical resection of their tumors will be enrolled, and the study will monitor outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary soft tissue sarcoma of the extremity who have had margin-negative surgical resection.
Not a fit: Patients with unresectable tumors or those who have not undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to effective treatment with fewer long-term side effects for patients with soft tissue sarcoma.
How similar studies have performed: Other studies have explored dose reduction in radiation therapy, showing promising results, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All protocol activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (All protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All protocol activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All protocol activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kaled Alektiar, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Kaled Alektiar, MD
- Email: alektiak@mskcc.org
- Phone: 212-639-7981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.