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CRYORLEvaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study

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What is being tested

local cryotherapy treatment

Procedure
Who is being recruted

Head and Neck Neoplasms

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2024
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Summary

Principal SponsorUniversity Hospital, Strasbourg, France
Study ContactLuigi Roberto CAZZATO, MD
Last updated: January 28, 2026
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Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

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.

Official TitleEvaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
Principal SponsorUniversity Hospital, Strasbourg, France
Study ContactLuigi Roberto CAZZATO, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

11 inclusion criteria required to participate
Malignant head/neck tumor

Unresectable locoregional recurrence in a previously irradiated area

Contraindication to re-irradiation

Age > 18 years

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13 exclusion criteria prevent from participating
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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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Hôpitaux Universitaires de Strasbourg

Strasbourg, FranceOpen Hôpitaux Universitaires de Strasbourg in Google Maps
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One Study Center