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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Desmoid Fibromatosis; Desmoid Tumor; Desmoid
• Intervention / Treatment: Procedure: radiofrequency ablation

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Artem Galustov; Phone Number: 9169117818; Email: artem115583@mail.ru

Study Locations

• Russian Federation
  • MO
    • Moscow, MO, Russian Federation, 115522
      • 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)
      • Principal Investigator: Aslan Valiev, PhD
      • Contact: Artem Galustov; Phone Number: 9169117818; Email: artem115583@mail.ru
      • Sub-Investigator: Denis Sofronov, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Desmoid; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	Proportion of patients who have a partial or complete response to therapy	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	The time from randomization to disease progression or death for patients who achieve complete or partial alleviation	3 years
Comparison of tumor necrosis based on MRI/CT	Proportion of tumor necrosis after therapy	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

Collaborators and Investigators

• Sponsor: Blokhin's Russian Cancer Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 29, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibromatosis, Aggressive; Fibroma
• Other Study ID Numbers: RFAdesmoid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No