cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Jean Perrin
About this trial
The goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma.
The main question it aims to answer is :
\- Does circulating DNA (cDNA) be able to detect residual disease 3 months after the end of chemoradiotherapy ? Researchers will compare detection of cDNA at 3-months and objective response (clinical and radiological).
Participants will :
* be included in the main study (Neck-TAR) * have a blood sample 1 and 3-month after the end of treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient included in NeckTAR study
Written informed consent signed for NeckTAR-IN study
Affiliation to the French social security system
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
blood sampling
Biological/VaccineThe intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy
Treatment groups
59 Participants
are divided into 1 treatment groupGroup A: cDNA detectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
cDNA detection and objective response 3 months after the end of chemoradiotherapy
The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)
Time frame
3 months after chemoradiotherapySecondary outcomes
1
cDNA detection and objective response one month after the end of chemoradiotherapy
The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)
Time frame
1 month after the end of chemoradiotherapy2
Overall survival
The overall survival is defined as the time between the date of inclusion and the date of death from any cause.
Time frame
At the end of the main study (27 months after the end of treatment)3
Progression-free survival
The progression-free survival is defined as the time between the date of inclusion and the date of the first progression of the disease (clinical or radiological) or death from any cause.
Time frame
At the end of the main study (27 months after the end of treatment)4
cDNA kinetic
cDNA detection at 1 and 3 months after the end of chemoradiotherapy
Time frame
1- and 3-month after the end of chemoradiotherapySponsors and contacts
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Source ClinicalTrials.gov