Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed. On days 2-3, topometric preparation is carried out, the choice of the amount of irradiation, the calculation of the program. On the 4-5th day after the operation, a course of intra-tissue radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy. (from 40 to 70 IGy). Follow-up examination after 4 weeks and then every 3 months for 24 months
1 day before the operation, taking blood tests: general blood test with counting the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram; performing surgical treatment with urgent histological examination of the edge of the tumor; intraoperatively, in the bed of the removed tumor, a surgical mesh is sutured onto which the intrastats are fixed with the fixation of the outlet ends on the skin with the help of buttons. 1 day after the operation, taking blood tests: a general blood test with the calculation of the leukocyte formula and the number of platelets; biochemical blood test with the determination of indicators of liver and kidney function (including electrolytes); coagulogram.
On the 2-3rd day after the surgical treatment, topometric preparation, the choice of the amount of radiation, and the calculation of the program are carried out. On the 4-5th day after the operation, a course of interstitial radiation therapy begins in a single dose of 3 to 5 Gy in 10 fractions 2 times a day with an interval between fractions of 6 hours, the planned total dose is from 30 to 50 Gy, which is equivalent to 40 to 70 IGy (isogrey). On the 6th day, removal of intrastats, on the 7th day after the operation, ultrasound of the wound and n / c vessels; assessment of the nature of wound healing. On the 10th day, discharge from the hospital.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interstitial radiation therapy | Experimental | Duration: 11 days |
|
| Postoperative external beam therapy, on the bed of the removed tumor | Active Comparator | Duration: 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interstitial radiation therapy | Radiation | From 30 to 50 Gy, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | Time after treatment during which no sign of cancer is found | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of hospitalization rate | Time after surgery till the end of hospitalization | 30 days |
| Comparison of safety assessment | Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denis Burov, PhD | Contact | +79265585000 | denisburov@yandex.ru |
| Name | Affiliation | Role |
|---|---|---|
| Aslan Valiev, PhD | N.N. Blokhin NMRCO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation | Recruiting | Moscow | 115478 | Russia |
Not provided
| Label | URL |
|---|---|
| official site | View source |
| russian surcoma group site | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Postoperative external beam therapy |
| Radiation |
50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin |
|
| 24 months |
| Comparison of performance status according Karnofsky scale | Improvement on the Karnofsky scale by 10-30 points | 24 months |
| Comparison of pain relief according Visual Analogue Scale | Improvement on the Visual Analogue Scale by 3-5 points | 24 months |
| Comparison of pain relief according Whatkins scale | Improvement on the Whatkins scale by 1-2 points | 24 months |
|