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NCT Number: NCT05738187

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

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.

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Key information

Conditions

Recurrent Head and Neck Cancer Head and Neck Neoplasms Local Cryotherapy Treatment Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Luigi Roberto CAZZATO, MD

CONTACT

[email protected]

03 69 55 16 35 ext. 0033

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

local cryotherapy treatment

Procedure

cryotherapy

Primary outcomes

  1. Local tumour control rate

    Time frame: at 12 months

    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.

Secondary outcomes

  1. Local tumour control rate

    Time frame: at 6 months post-procedure

    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.

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

    Time frame: at 12 months

    assessed by the NCI-CTCAE severity scale version 5.0

  3. To evaluate the quality of life of patients

    Time frame: at 1, 3, 6 and 12 months after cryotherapy

    Scale EORTC-QLQ-C30

  4. To evaluate the quality of life of patients

    Time frame: at 1, 3, 6 and 12 months after cryotherapy

    Scale EORTC - QLQ - H&N35

  5. To evaluate the quality of life of patients

    Time frame: at 1, 3, 6 and 12 months after cryotherapy

    Scale VHI 10

  6. To evaluate the quality of life of patients

    Time frame: at 1, 3, 6 and 12 months after cryotherapy

    Scale MDADI_v1.0

  7. To evaluate the quality of life of patients

    Time frame: at 1, 3, 6 and 12 months after cryotherapy

    Scale DHI

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Roberto CAZZATO, MD

CONTACT

[email protected]

03 69 55 16 35 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: CRYORL

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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