Can freezing tumors offer a new lifeline for head and neck cancer?
NCT ID NCT05738187
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This pilot study is investigating whether local cryotherapy—a procedure that freezes and destroys cancer cells—can control recurrent head and neck cancer in patients who have already received radiation therapy and cannot undergo surgery or further radiation. The trial will enroll 15 adults with unresectable, recurrent tumors in previously irradiated areas. The main goal is to see if cryotherapy can stop tumor growth without causing severe side effects, potentially offering a safer alternative to re-irradiation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- local cryotherapy treatment (a procedure that freezes and destroys cancer cells)
- What this could lead to
- If effective, cryotherapy could offer a new, less toxic treatment option for people with recurrent head and neck cancer who cannot have surgery or re-irradiation, potentially improving local control and survival.
- What could go wrong
- This is a small pilot study, so results may not be conclusive. Cryotherapy may not fully control the tumor, and there is a risk of complications or side effects, including damage to nearby tissues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * Stage IV with distant metastases or multiple tumors * Melanoma, sarcoma, and lymphoma * Participants who have received chemotherapy or radiation therapy within 4 weeks * 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) * Concomitant therapy with any other systemic anticancer treatment * Contraindication of anaesthesiology character * Contraindication to MRI * Participation in another clinical study * Any social, medical or psychological condition that may prevent the patient from complying with the constraints of the protocol * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, 67000, France
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