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

C

Centre Henri Becquerel

Status

Not yet enrolling

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Treatments

Other: Multimodal approach

Study type

Interventional

Funder types

Other

Identifiers

NCT07259915
CHB24.04

Details and patient eligibility

About

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.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

152 participants in 1 patient group

Multimodal approach
Experimental group
Description:
The patient will undergo multimodal imaging and biological sampling
Treatment:
Other: Multimodal approach

Trial contacts and locations

2

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Central trial contact

Doriane Richard, PhD; Lise-Marie Roussel, MD

Data sourced from clinicaltrials.gov

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