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NCT Number: NCT07259915

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

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.

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Key information

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel, Rouen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Multimodal approach

Other

The patient will undergo MRI, PET/can and biological samples

Primary outcomes

  1. Performance of multimodal approach to predict response to chemoradiation

    Time frame: 12 months after treatment

    Estimation of the area under the curve associated with the overall performance of the combined score established by the multimodal approach (PET/CT, MRI, CT, circulating tumor DNA, lymph node tumor DNA) in the post-CRT assessment of the status of a locoregional response within 12 months after chemoradiation.

Study contacts

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

Doriane Richard, PhD

CONTACT

[email protected]

+33232082985

Lise-Marie Roussel, MD

CONTACT

[email protected]

+33276015781

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Acronym: MULTINECK

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Dec 2, 2025
Registry last updated
Dec 2, 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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