Detecting residual disease in advanced head and neck cancer using blood samples after radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to improve the detection of residual disease in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) following potentiated radiotherapy. By analyzing circulating DNA from blood samples, the study seeks to provide a more sensitive and reliable method for assessing treatment outcomes compared to traditional imaging techniques. The trial will include patients aged 18 to 80 with specific types of HNSCC and will evaluate the effectiveness of this blood-based approach in predicting residual disease. The ultimate goal is to enhance patient management and treatment strategies for this challenging cancer type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years
* Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement
* squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)
* Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary
* Availability of FFPE samples prior to treatment initiation
* Detection of circulating DNA in the initial blood sample
* Obtaining informed consent from the patient
* Affiliation to the French social security system

Exclusion Criteria:

* Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer
* Treatment by exclusive radiotherapy
* Contraindication to cervical lymph node dissection
* Metastatic disease (stage IVc)
* Previous treatment for head and neck cancer
* History of other cancer in the last 3 years (except carcinoma in situ, basal cell skin carcinoma, localized prostate cancer Gleason 6)
* Pregnant or breastfeeding woman
* Patient under guardianship or curators
* Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial or compliance with the treatment

Where it's running

• Centre Jean PERRIN
  Clermont-Ferrand, Puy-de-Dôme, France Recruiting
• Centre Hospitalier Henri Mondor
  Aurillac, France Recruiting
• Hôpital de la Croix-Rousse
  Lyon, France Recruiting
• CHU de Saint-Étienne
  Saint-Etienne, France Recruiting

Study contacts

• Principal investigator: Maureen BERNADACH, MD — Centre Jean Perrin
• Study coordinator: Angeline GINZAC COUVÉ, PhD
• Email: angeline.ginzac@clermont.unicancer.fr
• Phone: 0463663337

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using gabapentin and ketamine to manage pain in head and neck cancer patients

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.