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Not yet recruitingNCT07259915MULTINECKUpdated Dec 2, 2025

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

An interventional study of Multimodal approach in Squamous Cell Cancer of Head and Neck (SCCHN), sponsored by Centre Henri Becquerel. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Squamous Cell Cancer of Head and Neck (SCCHN)

Keywords

  • multimodal approach
  • CT DNA
  • Resonance Magnetic Imaging
03

In context

Lead sponsor

Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Multimodal approach

    The patient will undergo multimodal imaging and biological sampling

    Other: Multimodal approach

Interventions

  • OtherMultimodal approach

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

06

What researchers measure

Primary outcomes

  1. Performance of multimodal approach to predict response to chemoradiation

    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.

    Time frame: 12 months after treatment

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07259915
Lead sponsor
Centre Henri Becquerel
Responsible party
Sponsor
First posted
Dec 2, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Aug 1, 2030 (estimated)
Completion
Aug 1, 2030 (estimated)
Last update
Dec 2, 2025

Study contacts

Lise-Marie Roussel, MD
Contact
lise-marie.roussel@chb.unicancer.fr
+33276015781
Doriane Richard, PhD
Contact
doriane.richard@chb.unicancer.fr
+33232082985

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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