Clinical trial NCT06355921: A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
Official title: A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Desmoid Tumor
Desmoid Fibromatosis
Desmoid
Lead sponsor: Blokhin's Russian Cancer Research Center
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 \&gt; 55%
9. Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count \&lt; 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

Primary outcomes:
measure: Comparison of safety assessment.
timeFrame: 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:
measure: Overall Response Rate
timeFrame: 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
measure: Duration of responce
timeFrame: 3 years
measure: Comparison of tumor necrosis based on MRI/CT
timeFrame: 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
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: 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)
state: MO
Study officials:
References: