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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Head and Neck Cancer; Local Cryotherapy Treatment
• Intervention / Treatment: Procedure: local cryotherapy treatment

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luigi Roberto CAZZATO, MD; Phone Number: 0033 03 69 55 16 35; Email: roberto-luigi.cazzato@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67000
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Luigi Roberto CAZZATO, MD; Phone Number: 0033 03 69 55 16 35; Email: robertoluigi.cazzato@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: local cryotherapy treatment	Procedure: local cryotherapy treatment; cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Head and Neck Neoplasms; Recurrence
• Other Study ID Numbers: 8761 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No