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

November 21, 2025 updated by: Centre Henri Becquerel
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal approach
The patient will undergo multimodal imaging and biological sampling
Other: Multimodal approach
The patient will undergo MRI, PET/can and biological samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHB24.04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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