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ClinicalTrials.gov ID

NCT07259915

Lead Sponsor

Centre Henri BecquerelOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

152Estimated

Last Update Posted

Dec 2, 2025Actual

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Aug 1, 2030Estimated

Completion Date

Aug 1, 2030Estimated

Official Title

Multimodal Prediction of Response to Chemoradiotherapy for Squamous Cell Carcinoma of the Head and Neck

Brief Summary

The goal of the study lies in offering a multimodal analysis of the post-therapeutic response based on both quantitative parameters and radiomics (CT, MRI, and PET imaging), and on tumor biology, in particular the hypersensitive detection of tumor DNA.

• Squamous Cell Cancer of Head and Neck (SCCHN)

• Multimodal approach

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patient with squamous cell carcinoma of the oropharynx (cT2-cT4) or squamous cell carcinoma of the oral cavity (cT2-cT4)
• With lymph node involvement (cN1, cN2, or cN3) (confirmation of lymph node involvement after review of imaging in CCP and without histological confirmation required)
• Eligible for curative treatment with cisplatin-based chemoradiotherapy alone (100 mg/m2 every 3 weeks or 40 mg/m2 weekly)
• Regardless of p16 status
• Affiliated with or covered by a social security system

Exclusion Criteria:

• Head and neck squamous cell carcinomas in other locations (salivary gland, larynx, hypopharynx, cavum, sinuses)
• Primary squamous cell carcinoma of the lymph nodes
• History of radiotherapy to the head and neck region
• Radiochemotherapy not based on the use of cisplatin
• Pregnant or breastfeeding women
• History of invasive cancer in the last 3 years (except for Breslow melanoma less than 1 mm)
• Contraindication to MRI, CT, or PET/CT
• Allergy or contraindication to iodine, gadolinium, or 18F-FDG
• Uncontrolled diabetes (fasting blood glucose greater than 12 mmol/l)
• Patients unable to understand the study for any reason or to comply with the trial requirements (language, psychological, geographical issues, etc.)
• Patients under guardianship or conservatorship
• Patients deprived of their liberty by judicial or administrative decision
• Patients undergoing psychiatric care that renders them incapable of giving their consent
• Patients admitted to a health or social care facility for purposes other than research

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Henri BecquerelOTHER

sophie.deneuve@chb.unicancer.fr+33232888990