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

NCT05738187 | Recruiting

• 1 other identifier: 8761
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Head and Neck Cancer; Local Cryotherapy Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Local tumour control rate

  at 6 months post-procedure

• Rate of complications/adverse events (including serious) possibly related to cryotherapy

  at 12 months

• To evaluate the quality of life of patients

  at 1, 3, 6 and 12 months after cryotherapy

• To evaluate the quality of life of patients

  at 1, 3, 6 and 12 months after cryotherapy

• To evaluate the quality of life of patients

  at 1, 3, 6 and 12 months after cryotherapy

Study Arms (1)

local cryotherapy treatment

EXPERIMENTAL

Procedure: local cryotherapy treatment

Interventions

local cryotherapy treatment PROCEDURE

cryotherapy

local cryotherapy treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Luigi Roberto CAZZATO, MD

CONTACT

03 69 55 16 35; roberto-luigi.cazzato@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)