Clinical trial · Interventional
Multimodal Prediction of Response to Chemoradiotherapy for Squamous Cell Carcinoma of the Head and Neck
NCT07259915CI-TRIAL-00098233MULTINECKnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Cancer of Head and Neck (SCCHN) | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal approach | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multimodal approach
- description
- The patient will undergo multimodal imaging and biological sampling
- interventionNames
- Other: Multimodal approach
Primary outcomes (1)
- measure
- Performance of multimodal approach to predict response to chemoradiation
- timeFrame
- 12 months after treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.