About this trial
Combined treatment of soft tissue sarcoma includes 3 steps:
1. step - preoperative stereotactic radiation therapy in hypofractionation mode 2. step - operation 3. step - postoperative conformal radiation therapy in normofractionation mode
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
morphologically verified diagnosis of soft tissue sarcoma
first diagnosed tumor process
ability to perform radical surgery
signed informed consent
Disqualifiers
previous radiation treatment
acute infection
pregnancy, lactation
recurrent tumor
Trial design
Single group
Treatments tested in this trial
Preoperative stereotactic radiation therapy in hypofractionation mode
RadiationAt the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues. At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation. GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy.
Surgery
Procedure/SurgeryIn 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
Postoperative conformal radiation therapy in normofractionation mode
RadiationIn 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm. PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.
Treatment groups
Trial outcomes
Primary outcomes
Complications
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
Secondary outcomes
Disease-Free survival
Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.
Sponsors and contacts
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