Desmoid TumorRFAdesmoidNCT06355921
A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
A study testing radiofrequency ablation in people with Desmoid Tumor and Desmoid Fibromatosis, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Desmoid Tumor, Desmoid Fibromatosis, Desmoid
- What is being tested?
- radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteRussia
- Study dates
- 1 Apr 2024to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
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- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
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
Artem Galustov, 9169117818, artem115583@mail.ru
Aslan Valiev, PhD
About this study
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
- Being tested
- radiofrequency ablation
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of safety assessment.
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Measured: 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
Proportion of patients who have a partial or complete response to therapy
Measured: 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
Measured: 3 years
Comparison of tumor necrosis based on MRI/CT
Proportion of tumor necrosis after therapy
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355921
- Sponsor's protocol ID
- RFAdesmoid
- Acronym
- RFAdesmoid
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
- ClinicalTrials.gov ID
- NCT06355921
- Acronym / sponsor ID
- RFAdesmoid / RFAdesmoid
- Conditions
- Desmoid Tumor, Desmoid Fibromatosis, Desmoid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmoid | Experimental | Procedure: radiofrequency ablationAdult 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablationAnesthesia: 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. | Procedure or surgery | Desmoid |
Primary outcome
Comparison of safety assessment.
Time frame: 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
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
3 secondary outcomes
Overall Response Rate
Time frame: 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
Time frame: 3 years
Comparison of tumor necrosis based on MRI/CT
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Yes
Related trials for Desmoid Tumor
RecruitingPhase 2
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RecruitingPhase 4
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Desmoid Tumor, Aggressive Fibromatosis
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Active, not recruitingPhase 2
A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery
Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis
Enrolling by invitationObservational study
Patient-reported Outcomes Following Percutaneous Ablation of Desmoid Tumors
Desmoid Tumor, Aggressive Fibromatoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency ablation in people with Desmoid Tumor and Desmoid Fibromatosis, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Artem Galustov (9169117818, artem115583@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of safety assessment. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.