Squamous Cell Cancer of Head and Neck (SCCHN)
Conditions
Keywords
multimodal approach, CT DNA, Resonance Magnetic Imaging
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.
Interventions
OTHERMultimodal approach
The patient will undergo MRI, PET/can and biological samples
Sponsors
Centre Henri Becquerel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of multimodal approach to predict response to chemoradiation | 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. |
Countries
France
Contacts
Primary ContactLise-Marie Roussel, MD
Backup ContactDoriane Richard, PhD
Outcome results
None listed