Soft Tissue Sarcoma Adult
Conditions
Brief summary
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
Detailed description
Combined treatment of soft tissue sarcoma includes 3 steps: 1. At 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. 2. Second step is surgery in 14-21 days. 3. In 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.
Interventions
RADIATIONPreoperative stereotactic radiation therapy in hypofractionation mode
At 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.
PROCEDURESurgery
In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
RADIATIONPostoperative conformal radiation therapy in normofractionation mode
In 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.
Sponsors
N.N. Petrov National Medical Research Center of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 year | Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free survival | 3 year | Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear. |
Countries
Russia
Contacts
Primary ContactGrigory Zinovev, PhD
Outcome results
None listed