Local cryotherapy for recurrent head and neck cancer in previously irradiated areas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study evaluates the efficacy and safety of local cryotherapy as a treatment for patients with recurrent head and neck cancer in areas that have previously received radiation. Given the challenges of treating unresectable locoregional recurrences, this approach aims to provide an alternative to standard palliative treatments, which often have limited effectiveness and significant toxicity. The study will enroll patients who meet specific criteria, including age and performance status, to assess the potential benefits of cryotherapy in improving local control of the disease.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Luigi Roberto CAZZATO, MD
• Email: roberto-luigi.cazzato@chru-strasbourg.fr
• Phone: 03 69 55 16 35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.