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Not yet recruiting NCT07259915

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

No phase Interventional Squamous Cell Cancer of Head and Neck (SCCHN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal approach.
Who it may be relevant to
Registry conditions: Squamous Cell Cancer of Head and Neck (SCCHN). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Multimodal approach
    The patient will undergo MRI, PET/can and biological samples

Primary outcome measures

  • Performance of multimodal approach to predict response to chemoradiation [Time frame: 12 months after treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 2 centers
  • Centre Henri Becquerel — Rouen
  • Centre Hospitalier Universitaire — Rouen

Identifiers

NCT: NCT07259915 · CHB24.04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗