Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical Treatment (CRYODESMO01)
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|ClinicalTrials.gov Identifier: NCT02476305|
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Desmoid Tumors||Device: "cryoprobes"||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Cryodestruction of Non Abdominopelvic Desmoid Tumors in Patients Progressing Despite Medical|
|Actual Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
patients undergo cryoablation procedure for desmoid tumor
Patient undergo percutaneous cryoablation of desmoid tumor, with cryoprobes
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476305
|Service d'Imagerie Interventionnelle|
|Strasbourg, Alsace, France, 67091|
|Principal Investigator:||Afshin GANGI, MD||Strasbourg's University Hospitals|