Multimodal Prediction of Response to Chemoradiotherapy for Squamous Cell Carcinoma of the Head and Neck
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Henri Becquerel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Multimodal approach
Other interventionThe patient will undergo MRI, PET/can and biological samples
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: Multimodal approachExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: