Combined treatment for soft tissue sarcoma using radiation therapy and surgery
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
This study is testing a new three-step treatment for people with soft tissue sarcoma that combines radiation therapy before and after surgery to see if it helps improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT04330456 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a three-step treatment approach for patients with soft tissue sarcoma. Initially, patients receive preoperative stereotactic radiation therapy in a hypofractionation mode, followed by surgery 14-21 days later. After surgery, postoperative conformal radiation therapy is administered according to standard protocols. The radiation therapy plans are meticulously designed using MRI and CT scans to ensure precise targeting of the tumor and surrounding tissues.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a morphologically verified diagnosis of soft tissue sarcoma who are eligible for radical surgery.
Not a fit: Patients with recurrent tumors, previous radiation treatment, or conditions that may affect treatment outcomes are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and reduce the risk of tumor recurrence in patients with soft tissue sarcoma.
How similar studies have performed: Other studies have shown promising results with similar combined approaches of radiation therapy and surgery for soft tissue sarcoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * morphologically verified diagnosis of soft tissue sarcoma * first diagnosed tumor process * ability to perform radical surgery * signed informed consent * indications for stereotactic and conformal radiation therapy * no contraindications for radiation and surgical treatment Exclusion Criteria: * previous radiation treatment * acute infection * pregnancy, lactation * recurrent tumor * refuse to sign informed consent * conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.) * tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
Where this trial is running
Saint Petersburg
- National Research Center of Oncology named after N.N.Petrov — Saint Petersburg, Russia (Recruiting)
Study contacts
- Study coordinator: Grigory Zinovev, PhD
- Email: zinovevgrigory@gmail.com
- Phone: +79213405814
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.