Clinical trial NCT05057195: Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy
Official title: Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy in Patients With Soft Tissue Sarcomas of the Upper and Lower Extremities Compared With Postoperative Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma
Soft Tissue Sarcoma
Keywords: Sarcoma
Soft Tissue Sarcoma
Lead sponsor: Blokhin's Russian Cancer Research Center
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* C49.1 Malignant neoplasm of the connective and soft tissues of the upper limb, including the shoulder girdle
* C49.2 Malignant neoplasm of the connective and soft tissues of the lower limb, including the hip region
* Tumor size 7 cm or less
* For malignant tumors: Grade 2-3
* Locally advanced soft tissue sarcomas
* Absence of regional metastases
* Tumor recurrence

Exclusion Criteria:

* Children, women during pregnancy, childbirth, women during breastfeeding.
* Military personnel, with the exception of contract military personnel.
* Persons with mental disorders.
* Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest.
* The age of patients is under 18 years old
* Histologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar, clear cell sarcoma, chondrosarcoma, paraossal osteosarcoma
* Inoperable tumor
* A tumor with decay or with the threat of decay
* The presence of damage to the skin in the affected area
* The presence of a second malignant tumor
* Having an active or chronic fungal / bacterial / viral infection
* Uncontrolled chronic diseases of the liver, kidneys in the acute stage
* Superficial tumor (within the skin)
* The use of a reconstructive plastic component using a displaced musculocutaneous flap
* The use of vascular prosthetics
* The removed tumor bed is more than 7 cm
* The presence of a tumor growing into the bone
* The presence of blood vessels and nerves in the removed tumor bed
* Presence of metastases
* Surgical intervention using transplanted skin

Primary outcomes:
measure: disease-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Comparison of hospitalization rate
timeFrame: 30 days
measure: Comparison of safety assessment
timeFrame: 24 months
measure: Comparison of performance status according Karnofsky scale
timeFrame: 24 months
measure: Comparison of pain relief according Visual Analogue Scale
timeFrame: 24 months
measure: Comparison of pain relief according Whatkins scale
timeFrame: 24 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Study officials:
affiliation: N.N. Blokhin NMRCO
name: Aslan Valiev, PhD
role: PRINCIPAL_INVESTIGATOR
References: