A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors

NCT06355921 | Not Yet Recruiting DMC

• 1 other identifier: RFAdesmoid
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors. In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month. In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.

Conditions

Desmoid Tumor; Desmoid Fibromatosis; Desmoid

Outcome Measures

Primary Outcomes (1)

• Comparison of safety assessment.

  Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

  The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy

Secondary Outcomes (3)

• Overall Response Rate

  The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy

• Duration of responce

  3 years

• Comparison of tumor necrosis based on MRI/CT

  The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy

Study Arms (1)

Desmoid

EXPERIMENTAL

Adult patients with desmoid tumors in the soft tissues of the extremities, trunk and paravertebral region of both sexes.In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month. In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.

Procedure: radiofrequency ablation

Interventions

radiofrequency ablation PROCEDURE

Anesthesia: Local (Novocaine, Lidocaine, Bupivacaine) Access: transcutaneous Navigation under CT control Cannulas are used: 22G 100 and 150 mm, the size of the electrode corresponds to the size of the cannula The starting power is 20W followed by steps of 10W every 2 minutes until the maximum power is reached, the maximum power is 60W. In order to prevent infectious complications, two-day antibiotic prophylaxis of Cefazolin (1g) is carried out 3 times a day In order to prevent skin burns with superficially located DFS, the skin is cooled during the procedure.

Desmoid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically verified diagnosis of dermoid tumor
• The presence of progressive, symptomatic or functionally significant DF.
• Written Informed consent to participate in the study
• Age from 18 to 75 years
• The functional status of the patient according to the ECOG 0-2 scale
• Normal renal function (estimated creatinine clearance 60 ml/min);
• Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);
• Left ventricular ejection fraction \> 55%
• Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count \< 100 thousand/ml);

You may not qualify if:

• The inability to obtain informed consent to participate in the study
• Synchronous or metachronous cancer
• Clinically significant diseases of the cardiovascular system
• Clinically significant CNS diseases
• Previous grade 2 polyneuropathy and above
• Current infection or other severe or systemic disease that increases the risk of complications of therapy
• Pregnancy, lactation

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 (N.N. Blokhin NMRCO)

Moscow, Moscow Oblast, 115522, Russia

Location

MeSH Terms

Conditions

Desmoid Tumors

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Artem Galustov

CONTACT

9169117818; artem115583@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

RU (1)