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

NCT ID: NCT07259915

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Squamous Cell Cancer of Head and Neck (SCCHN)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multimodal approach

The patient will undergo multimodal imaging and biological sampling

Group Type EXPERIMENTAL

Multimodal approach

Intervention Type OTHER

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

Interventions

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Multimodal approach

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Henri Becquerel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Henri Becquerel

Rouen, , France

Site Status

Centre Hospitalier Universitaire

Rouen, , France

Site Status

Countries

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France

Central Contacts

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Lise-Marie Roussel, MD

Role: CONTACT

+33276015781

Doriane Richard, PhD

Role: CONTACT

+33232082985

Facility Contacts

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Lise-Marie Roussel, Md

Role: primary

+33276015781

Sophie Deneuve

Role: primary

+33232888990

Other Identifiers

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CHB24.04

Identifier Type: -

Identifier Source: org_study_id

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