Last updated: March 29, 2024
Sponsor: Blokhin's Russian Cancer Research Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Sarcoma
Sarcoma (Pediatric)
Soft Tissue Sarcoma
Treatment
Interstitial radiation therapy
Postoperative external beam therapy
Clinical Study ID
NCT05057195
SARCBT-2021-7-11
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 offreedom, arrest, imprisonment or administrative arrest.
- The age of patients is under 18 years old
- Histologically confirmed diagnosis of GIST, Kaposi's sarcoma, alveolar, clear cellsarcoma, 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
Study Design
Total Participants: 78
Treatment Group(s): 2
Primary Treatment: Interstitial radiation therapy
Phase:
Study Start date:
January 10, 2022
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Moscow, 115478
Russian FederationActive - Recruiting
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