RecruitingNot ApplicableNCT05738187

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


Sponsor

University Hospital, Strasbourg, France

Enrollment

15 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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%). 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether a treatment called cryotherapy (using extreme cold to destroy tumor tissue) is safe and effective for people with head and neck cancer that has come back in an area that was previously treated with radiation and cannot be operated on again. **You may be eligible if...** - You have a head or neck cancer that has come back (recurred) in a previously irradiated area - Surgery or re-irradiation is not an option for you - You are over 18 years old - You are in reasonably good general health (WHO performance index ≤ 2) - Your life expectancy is more than 12 weeks - Your kidney function is adequate **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body, or you have multiple tumors - Your cancer type is melanoma, sarcoma, or lymphoma - You have had chemotherapy or radiation in the past 4 weeks - You have another active cancer diagnosed in the past 2 years (some early-stage cancers are exceptions) - You are currently receiving other systemic cancer treatments - You are pregnant - You have a contraindication to MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURElocal cryotherapy treatment

cryotherapy


Locations(1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05738187


Related Trials