Wide Excision of Soft Tissue Sarcomas in Combination With Interstitial Radiation Therapy

NCT05057195 | Recruiting

• 1 other identifier: SARCBT-2021-7-11
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Sarcoma; Soft Tissue Sarcoma

Keywords

Sarcoma; Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  Time after treatment during which no sign of cancer is found

  24 months

Secondary Outcomes (5)

• Comparison of hospitalization rate

  30 days

• Comparison of safety assessment

  24 months

• Comparison of performance status according Karnofsky scale

  24 months

• Comparison of pain relief according Visual Analogue Scale

  24 months

• Comparison of pain relief according Whatkins scale

  24 months

Study Arms (2)

Interstitial radiation therapy

EXPERIMENTAL

Duration: 11 days

Radiation: Interstitial radiation therapy

Postoperative external beam therapy, on the bed of the removed tumor

ACTIVE COMPARATOR

Duration: 4 weeks

Radiation: Postoperative external beam therapy

Interventions

Interstitial radiation therapy RADIATION

From 30 to 50 Gy,

Interstitial radiation therapy

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

Postoperative external beam therapy, on the bed of the removed tumor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

Moscow, 115478, Russia

RECRUITING

Related Links

• official site
• russian surcoma group site

MeSH Terms

Conditions

Sarcoma

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Aslan Valiev, PhD

  N.N. Blokhin NMRCO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denis Burov, PhD

CONTACT

+79265585000; denisburov@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: January 10, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)