Recurrent Head and Neck CancerCRYORLNCT05738187
Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
A study testing local cryotherapy treatment in people with Recurrent Head and Neck Cancer and Local Cryotherapy Treatment, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Cancer, Local Cryotherapy Treatment
- What is being tested?
- local cryotherapy treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Luigi Roberto CAZZATO, MD, 03 69 55 16 35 ext. 0033, robertoluigi.cazzato@chru-strasbourg.fr
About this study
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.
Read more
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.
- Being tested
- local cryotherapy treatment
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local cryotherapy treatmentProcedure or surgery
cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| local cryotherapy treatment | Experimental | Not described Receives: Procedure: local cryotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumour control rate
Tumour control is defined as no increase in size and no suspicious contrast (or radiotracer) in the ablation area. Any suspected recurrence on cross-sectional imaging will be confirmed by biopsy.
Measured: at 12 months
Secondary outcomes (7)
Local tumour control rate
Tumour control is defined as no increase in size and no suspicious contrast (or radiotracer) in the ablation area. Any suspected recurrence on cross-sectional imaging will be confirmed by biopsy.
Measured: at 6 months post-procedure
Rate of complications/adverse events (including serious) possibly related to cryotherapy
assessed by the NCI-CTCAE severity scale version 5.0
Measured: at 12 months
To evaluate the quality of life of patients
Scale EORTC-QLQ-C30
Measured: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Scale EORTC - QLQ - H\&N35
Measured: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Scale VHI 10
Measured: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Scale MDADI_v1.0
Measured: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Scale DHI
Measured: at 1, 3, 6 and 12 months after cryotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jan 2024
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CancerStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738187
- Sponsor's protocol ID
- 8761
- Acronym
- CRYORL
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
- ClinicalTrials.gov ID
- NCT05738187
- Acronym / sponsor ID
- CRYORL / 8761
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| local cryotherapy treatment | Experimental | Procedure: local cryotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Malignant head/neck tumor
- Unresectable locoregional recurrence in a previously irradiated area
- Contraindication to re-irradiation
- Age > 18 years
- Performance index ≤ 2 (WHO)
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| local cryotherapy treatmentcryotherapy | Procedure or surgery | local cryotherapy treatment |
Primary outcome
Local tumour control rate
Time frame: at 12 months
Tumour control is defined as no increase in size and no suspicious contrast (or radiotracer) in the ablation area. Any suspected recurrence on cross-sectional imaging will be confirmed by biopsy.
7 secondary outcomes
Local tumour control rate
Time frame: at 6 months post-procedure
Rate of complications/adverse events (including serious) possibly related to cryotherapy
Time frame: at 12 months
To evaluate the quality of life of patients
Time frame: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Time frame: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Time frame: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Time frame: at 1, 3, 6 and 12 months after cryotherapy
To evaluate the quality of life of patients
Time frame: at 1, 3, 6 and 12 months after cryotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local cryotherapy treatment in people with Recurrent Head and Neck Cancer and Local Cryotherapy Treatment, 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Roberto CAZZATO, MD (03 69 55 16 35 ext. 0033, roberto-luigi.cazzato@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumour control rate (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.