Desmoid TumorsCRYODESMO01NCT02476305
Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical Treatment
A study testing "cryoprobes" in people with Desmoid Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from musculoaponeurotic structures. Although they are benign tumors with no metastatic potential, DT are considered as locally aggressive tumors, with local invasiveness and tissue destruction, leading to pain, and disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Desmoid Tumors
- What is being tested?
- "cryoprobes"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- May 2015to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Extra-abdominal desmoid tumor (confirmed by prior biopsy)
- 18 years of age or older
- Tumor deemed accessible for cryoablation procedure by the operator in the investigator center
- At least one measurable lesion (RECIST v1.1) using MRI (gadolinium injection mandatory)
- 90 % of destruction of the tumor achievable in one procedure of cryoablation with a possible second cryoablation procedure (if a complete treatment must be achieved).
- Progressive disease under standard treatment (after at least two lines of adequate medical therapy, including tamoxifen, non-steroid anti-inflamatory or chemotherapy), with presence of functional symptoms and/or pain The definition of progressing tumors also involves patients with RECIST stable disease, but with persistent functional disability or tumor-induced pain not controlled by adequate pain medication including narcotics.
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- Unresectable tumor or tumor amenable only to mutilating surgery, deemed inappropriate, and discussed in multidisciplinary meeting (RCP)
- ECOG performance status 0-2
- Biological and hematological parameters:
- neutrophils 1,5.109/L
- platelet count 100.109/L
- No significant hemostatic abnormalities
- Subject affiliated to social security
- Signed informed consent
Who cannot join
- Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
- Impaired hemostasis, that may interfere with the conduct of the cryoablation
- Concurrent participation in other experimental studies that could affect endpoints of this study
- Contraindication to any form of sedation
- Contraindication to MRI or gadolinium injection (proven allergy, subject with impaired renal function (defined by a creatinine clearance below 30 ml/min by MDRD formula))
- Psychiatric disorders and adults under guardianship
- Pregnancy or breastfeeding
- Patients under judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical
Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from musculoaponeurotic structures. Although they are benign tumors with no metastatic potential, DT are considered as locally aggressive tumors, with local invasiveness and tissue destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root members). In patients where surgery is considered, negative-margin resection (R0) is recommended, but this frequently results in cosmetic/functional impairment. Moreover, prognostic impact of R0 resections remains controversial. The outcome after initial surgery depends upon several factors such as age, tumor site, and tumor size as demonstrated by recent data from the French Sarcoma Group.
Alternative therapies to DT surgery for front-line or recurrence include NSAID's, anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or radiation therapy. All of these medical approaches however may fail to achieve long-term disease control and a number of patients suffer from irreducible pain, and disability from tumor volume.
Read more
Cryoablation is a promising technique that is suitable for patients experiencing extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of the tumor, leading to cell death. The technique has many advantages, among which: the accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible with other techniques such as radiofrequency), the lack of mutilation, the possibility of repeating the procedure. The cryoablation procedure has proven to be beneficial for the treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with promising results.
In the light of these encouraging data, it is believed that patients with extra-abdominal DT not amenable to surgery unless unacceptable surgical sequel and progressing after at least two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms relief, prolonged progression-free survival and a better quality of life.
- Conditions
- Desmoid Tumors
- Being tested
- "cryoprobes"
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"cryoprobes"Device
Patient undergo percutaneous cryoablation of desmoid tumor, with cryoprobes
| Study group | Role | What they receive |
|---|---|---|
| cryoablation | Experimental | patients undergo cryoablation procedure for desmoid tumor Receives: Device: "cryoprobes" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-progression of non-abdominopelvic desmoid tumor
The success of cryoablation, i.e. non-progression of non-abdominopelvic desmoid tumor, will be declared if the MRI control at 1 year after the last procedure shows:
- no suspicious contrast enhancement (the suspicious character is defined by heterogeneous or nodular or crescent-shape contrast enhancement) in the treated zone,
- and if the cryolesion (ablation zone) is not increasing in size compared to early post-ablation control (M1)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Desmoid TumorsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Afshin GANGI, MD, Principal investigator, Strasbourg's University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476305
- Sponsor's protocol ID
- 6018
- Acronym
- CRYODESMO01
- Status last verified
- Nov 2017
- First submitted
- 4 Jun 2015
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurtz JE, Buy X, Deschamps F, Sauleau E, Bouhamama A, Toulmonde M, Honore C, Bertucci F, Brahmi M, Chevreau C, Duffaud F, Gantzer J, Garnon J, Blay JY, Gangi A. CRYODESMO-O1: A prospective, open phase II study of cryoablation in desmoid tumour patients progressing after medical treatment. Eur J Cancer. 2021 Jan;143:78-87. doi: 10.1016/j.ejca.2020.10.035. Epub 2020 Dec 5.
PubMed 33290994
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical
- ClinicalTrials.gov ID
- NCT02476305
- Acronym / sponsor ID
- CRYODESMO01 / 6018
- Conditions
- Desmoid Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 19 Jun 2015 (estimated)
- 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.
Desmoid tumors (DT) are rare tumors (2-4 cases/million/year) that originate from musculoaponeurotic structures. Although they are benign tumors with no metastatic potential, DT are considered as locally aggressive tumors, with local invasiveness and tissue destruction, leading to pain, and disability. Surgery remains the keystone of therapy, but is limited by the anatomical situation of extra-abdominal desmoid (EAD) tumors (chest wall, root members). In patients where surgery is considered, negative-margin resection (R0) is recommended, but this frequently results in cosmetic/functional impairment. Moreover, prognostic impact of R0 resections remains controversial. The outcome after initial surgery depends upon several factors such as age, tumor site, and tumor size as demonstrated by recent data from the French Sarcoma Group.
Alternative therapies to DT surgery for front-line or recurrence include NSAID's, anti-estrogens alone or in combination, -interferon, chemotherapy, targeted therapies or radiation therapy. All of these medical approaches however may fail to achieve long-term disease control and a number of patients suffer from irreducible pain, and disability from tumor volume.
Cryoablation is a promising technique that is suitable for patients experiencing extra-abdominal DT. The procedure is based on repeated cycles of freezing/passive thawing of the tumor, leading to cell death. The technique has many advantages, among which: the accurate control of iceball under real-time MRI or CT-scan monitoring (that is not possible with other techniques such as radiofrequency), the lack of mutilation, the possibility of repeating the procedure. The cryoablation procedure has proven to be beneficial for the treatment of various tumors (liver metastases, breast, kidney). Recently, percutaneous cryotherapy has been reported in the treatment of EAD tumors poorly suited to surgery, with promising results.
In the light of these encouraging data, it is believed that patients with extra-abdominal DT not amenable to surgery unless unacceptable surgical sequel and progressing after at least two lines of adequate medical therapy (tamoxifen, NSAID or chemotherapy), could benefit from the cryoablation procedure. Tumor cryotherapy-induced regression should allow symptoms relief, prolonged progression-free survival and a better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cryoablation | Experimental | Device: "cryoprobes"patients undergo cryoablation procedure for desmoid tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Extra-abdominal desmoid tumor (confirmed by prior biopsy)
- 18 years of age or older
- Tumor deemed accessible for cryoablation procedure by the operator in the investigator center
- At least one measurable lesion (RECIST v1.1) using MRI (gadolinium injection mandatory)
- 90 % of destruction of the tumor achievable in one procedure of cryoablation with a possible second cryoablation procedure (if a complete treatment must be achieved).
Key exclusion criteria (8 listed)
- Any contra-indication for the procedure as stated by the radiologist in terms of tumor size, proximity to neural/vascular structures making the procedure at unacceptable risk
- Impaired hemostasis, that may interfere with the conduct of the cryoablation
- Concurrent participation in other experimental studies that could affect endpoints of this study
- Contraindication to any form of sedation
- Contraindication to MRI or gadolinium injection (proven allergy, subject with impaired renal function (defined by a creatinine clearance below 30 ml/min by MDRD formula))
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 |
|---|---|---|
| "cryoprobes"Patient undergo percutaneous cryoablation of desmoid tumor, with cryoprobes | Device | cryoablation |
Primary outcome
Non-progression of non-abdominopelvic desmoid tumor
Time frame: 12 months
The success of cryoablation, i.e. non-progression of non-abdominopelvic desmoid tumor, will be declared if the MRI control at 1 year after the last procedure shows: * no suspicious contrast enhancement (the suspicious character is defined by heterogeneous or nodular or crescent-shape contrast enhancement) in the treated zone, * and if the cryolesion (ablation zone) is not increasing in size compared to early post-ablation control (M1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Results publication: PubMed 33290994Kurtz JE, Buy X, Deschamps F, Sauleau E, Bouhamama A, Toulmonde M, Honore C, Bertucci F, Brahmi M, Chevreau C, Duffaud F, Gantzer J, Garnon J, Blay JY, Gangi A. CRYODESMO-O1: A prospective, open phase II study of cryoablation in desmoid tumour patients progressing after medical treatment. Eur J Cancer. 2021 Jan;143:78-87. doi: 10.1016/j.ejca.2020.10.035. Epub 2020 Dec 5.
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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. This study is not recruiting at the moment.
Afshin GANGI, MD principal investigator
Strasbourg's University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "cryoprobes" in people with Desmoid Tumors, run by University Hospital, Strasbourg, France at 1 site in France.
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 14 inclusion and 8 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: finished, as of the sponsor's last update on 20 Jan 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-progression of non-abdominopelvic desmoid tumor (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02476305, which also lists 1 linked publication.
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 20 Jan 2026.