Clinical trial NCT04330456: Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
Official title: Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Soft Tissue Sarcoma Adult
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Complications
timeFrame: 3 year
Secondary outcomes:
measure: Disease-Free survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: National Research Center of Oncology named after N.N.Petrov
Study officials:
References: