Local cryotherapy for recurrent head and neck cancer in previously irradiated areas
Evaluation of the Efficacy and Safety of Local Cryotherapy Treatment of Recurrent Head and Neck Cancer in Irradiated Areas: a Pilot Study
This study is testing if local cryotherapy can help people with recurrent head and neck cancer in areas that have already been treated with radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05738187 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with unresectable locoregional recurrence of head and neck cancer in previously irradiated areas.
Not a fit: Patients with distant metastases or other active cancers may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with recurrent head and neck cancer, potentially improving survival and quality of life.
How similar studies have performed: While local cryotherapy is a novel approach in this context, similar studies in other cancer types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Strasbourg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.