NCT05738187Recruiting
Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
In France, squamous cell carcinomas of the head and neck (SCCHN) are the 5th most common cancer. 60% of patients present with locally advanced tumors (stage III/IV), characterized by a poor prognosis (5-year survival not exceeding 60%). The standard treatment consists of either surgical removal followed by adjuvant radiochemotherapy or exclusive radiochemotherapy. In case of locoregional recurrence (about 40% of patients), salvage surgery can be proposed, allowing prolonged survival for less than one third of eligible patients. However, more than half of locoregional recurrences are unresectable. The standard treatment then consists of immunotherapy and/or chemotherapy for palliative purposes with a median survival of no more than 15 months. Stereotactic radiotherapy is another potentially curative option that allows a local control of 30-60% at 1 year, but at the cost of significant toxicity (up to 50% of grade 3-4 toxicities), thus limiting its indication. The issue of salvage treatment also applies to other rarer histological forms, including naso-sinus and salivary gland tumors, for which the probability of overall survival at 5 years does not exceed 65% due to locoregional evolution, despite advances in surgical techniques and the addition of radiotherapy. During the last two decades, minimally invasive interventional radiology techniques have been developed in the field of oncology. Among these techniques, cryotherapy is now commonly used for the treatment of several cancers. The multiplication of its indications is based on numerous clinical advantages (good post-operative analgesia, good toxicity profile, good tumor control). Cryotherapy could thus be a therapeutic alternative in head and neck cancers in recurrence situation in irradiated and unresectable territory, allowing to maintain a curative project in a higher proportion of patients and also to have a more favorable toxicity profile than re-irradiation.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 30 Jan 2023
- Start date
- 1 Jan 2024
- Primary completion date
- Feb 2028
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Head and neck cancer
- NCT number
- NCT05738187
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 1 Jan 2024 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have received chemotherapy or radiation therapy within 4 weeks
- Concomitant therapy with any other systemic anticancer treatment
Other illness
- Other active cancer within the past 2 years (patients with carcinoma in situ, papillary thyroid carcinoma, basal cell skin carcinoma, localized Gleason 6 prostate cancer, or breast cancer in situ are allowed)
- Any social, medical or psychological condition that may prevent the patient from complying with the constraints of the protocol
Other
- Stage IV with distant metastases or multiple tumors
- Melanoma, sarcoma, and lymphoma
- Contraindication of anaesthesiology character
- Contraindication to MRI
- Participation in another clinical study
- Any significant pathology that may interfere with the patient's participation in the study
- Subject under court protection
- Subject under guardianship or curatorship
- Pregnant or breastfeeding women
Who the study is looking for
- Malignant head/neck tumor
- Unresectable locoregional recurrence in a previously irradiated area
- Contraindication to re-irradiation
- Age \> 18 years
- Performance index ≤ 2 (WHO)
- Life expectancy \> 12 weeks
- Absence of hemostasis disorders
- Renal function: creatinine clearance ≥ 30 mL/min by CKD-EPI method (Cockcroft-Gault formula or MDRD)
- Subject affiliated to a social security health insurance plan
- Subject able to understand the objectives and risks of the research and to give dated and signed informed consent
- For a woman of childbearing age, negative blood pregnancy test at the inclusion visit
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.