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

Recurrent Head and Neck Cancer Clinical Trial

— CRYORL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05738187
• Other study ID #: 8761
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Luigi Roberto CAZZATO, MD
• Phone: 03 69 55 16 35
• Email: roberto-luigi.cazzato[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%). 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: November 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Recurrence
• Recurrent Head and Neck Cancer

Intervention

Procedure:
• local cryotherapy treatment
cryotherapy

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at 12 months
Secondary	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.	at 6 months post-procedure
Secondary	Rate of complications/adverse events (including serious) possibly related to cryotherapy	assessed by the NCI-CTCAE severity scale version 5.0	at 12 months
Secondary	To evaluate the quality of life of patients	Scale EORTC-QLQ-C30	at 1, 3, 6 and 12 months after cryotherapy
Secondary	To evaluate the quality of life of patients	Scale EORTC - QLQ - H&N35	at 1, 3, 6 and 12 months after cryotherapy
Secondary	To evaluate the quality of life of patients	Scale VHI 10	at 1, 3, 6 and 12 months after cryotherapy
Secondary	To evaluate the quality of life of patients	Scale MDADI_v1.0	at 1, 3, 6 and 12 months after cryotherapy
Secondary	To evaluate the quality of life of patients	Scale DHI	at 1, 3, 6 and 12 months after cryotherapy