National Research Center of Oncology named after N.N.Petrov
Saint Petersburg, Russia
Location status: Recruiting
NCT Number: NCT04330456
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
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Saint Petersburg, Russia
Location status: Recruiting
Combined treatment of soft tissue sarcoma includes 3 steps:
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
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.
Time frame: 3 year
Rate of complications will be measured after completing each step of protocol: stereotactic radiation therapy, surgery and them postoperative conformal radiation therapy
Time frame: 3 year
Disease-Free survival will be evaluated after completing the protocol or during the protocol if local recurrence will appear.
Contact information is provided by the study sponsor or research team.
N.N. Petrov National Medical Research Center of Oncology
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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