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

Desmoid Tumor Clinical Trial

— RFAdesmoid  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355921
• Other study ID #: RFAdesmoid
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: April 2024
• Source: Blokhin's Russian Cancer Research Center
• Contact: Artem Galustov
• Phone: 9169117818
• Email: artem115583[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: May 1, 2028
• Est. primary completion date: February 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Desmoid
• Desmoid Fibromatosis
• Desmoid Tumor
• Fibroma

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" ?f the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO)	Moscow	MO

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of responce	The time from randomization to disease progression or death for patients who achieve complete or partial alleviation	3 years
Secondary	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