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

NCT07259915 | Not Yet Recruiting

• 1 other identifier: CHB24.04
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Squamous Cell Cancer of Head and Neck (SCCHN)

Keywords

multimodal approach; CT DNA; Resonance Magnetic Imaging

Outcome Measures

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.

  12 months after treatment

Study Arms (1)

Multimodal approach

EXPERIMENTAL

The patient will undergo multimodal imaging and biological sampling

Other: Multimodal approach

Interventions

Multimodal approach OTHER

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

Multimodal approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (2)

Centre Henri Becquerel

Rouen, France

Location

Centre Hospitalier Universitaire

Rouen, France

Location

Central Study Contacts

Lise-Marie Roussel, MD

CONTACT

+33276015781; lise-marie.roussel@chb.unicancer.fr

Doriane Richard, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)