Actively Recruiting
Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
Led by University Hospital, Strasbourg, France · Updated on 2025-08-08
15
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating local cryotherapy as a treatment for recurrent head and neck cancers located in previously irradiated areas. This pilot study focuses on patients with unresectable locoregional recurrences, who have limited treatment options and poor survival rates. Traditional treatments like surgery and radiochemotherapy have limited success or cause significant toxicity, creating a need for alternative therapies with better safety and effectiveness profiles. Participants will receive local cryotherapy treatment, a minimally invasive technique that uses extreme cold to destroy cancer tissues. This procedure is being studied as a potential alternative to re-irradiation or surgery for tumors that cannot be removed. The study aims to assess the local tumor control rate at 12 months after treatment and monitor any complications or adverse events related to cryotherapy. During the study, patients will be closely monitored with assessments of tumor control at 6 and 12 months, evaluation of any side effects, and quality of life questionnaires at 1, 3, 6, and 12 months post-treatment. The research team will track patients’ overall health, kidney function, and other safety factors. Participation includes follow-up visits to measure outcomes and ensure patient well-being throughout the study period.
CONDITIONS
Brief Title
Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Malignant head or neck tumor
- Unresectable locoregional recurrence in a previously irradiated area
- Contraindication to re-irradiation
- Age over 18 years
- Performance index less than or equal to 2 (WHO scale)
- Life expectancy greater than 12 weeks
- No bleeding or hemostasis disorders
- Kidney function with creatinine clearance at least 30 mL/min
- Affiliated with a social security health insurance plan
- Ability to understand the study and provide informed consent
- Negative pregnancy test for women of childbearing age at inclusion
You will not qualify if you...
- Stage IV cancer with distant metastases or multiple tumors
- Melanoma, sarcoma, or lymphoma diagnosis
- Chemotherapy or radiation therapy received within the last 4 weeks
- Other active cancers within past 2 years, except specific low-risk types
- Concurrent systemic anticancer treatments
- Contraindications related to anesthesia
- Contraindications to MRI
- Participation in another clinical study
- Any social, medical, or psychological condition preventing protocol compliance
- Significant illnesses interfering with participation
- Under court protection, guardianship, or curatorship
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment procedure with follow-up lasting up to 12 months
Participants receive local cryotherapy treatment for recurrent head and neck cancer in previously irradiated areas.
1 treatment visit and follow-up visits at 1, 3, 6, and 12 months
Duration - Up to 12 months post-treatment
Participants are monitored for local tumor control, complications, adverse events, and quality of life after cryotherapy.
Follow-up visits at 1, 3, 6, and 12 months after treatment
Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
Research Team
L
Luigi Roberto CAZZATO, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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