Measuring circulating tumor DNA in patients with advanced upper aero-digestive tract cancer 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 study evaluates the prognostic value of circulating tumor DNA (ctDNA) levels in patients with stage III and IV squamous cell carcinoma of the upper aero-digestive tract who are undergoing curative radiotherapy. It involves a multicenter cohort of 188 patients who are newly diagnosed and treatment-naïve, measuring ctDNA levels at one month post-treatment to predict progression-free survival and overall survival at 24 months. The study will analyze the reduction in ctDNA levels and its correlation with patient outcomes, considering factors such as HPV status and treatment type.

Why it matters

Who can join: the full rules

Inclusion Criteria

* OMS 0 to 2;
* Patient suffering from UADT squamous cell carcinoma, newly diagnosed and histologically proven, regardless of the p16 protein status, naïve to any treatment for this cancer;
* Non-metastatic cancer of stages III (N1), IVa (N1 minimum) or IVb;
* Cancer localized in the oral cavity, larynx, oropharynx, hypopharynx and maxillary sinus;
* Patient for whom treatment with curative radiotherapy associated or not with concomitant treatment (Cisplatin or Cetuximab) has been validated in a multidisciplinary consultation meeting (RCP);
* Patient capable and willing to follow all study procedures in accordance with the protocol;
* Patient having understood, signed and dated the consent form communicated on the day of inclusion;
* Patient affiliated to the social security system.

Exclusion Criteria:

* Minor patient;
* Cancer located in the cavum, ethmoidal sinus, salivary glands and skin (cutaneous squamous cell carcinoma);
* Patient already treated for UADT tumor;
* Patient treated with immunotherapy;
* Patient who has already had cancer within 5 years (cancer other than in the UADT sphere);
* OMS \> 2;
* Contraindication to radiotherapy treatment associated or not with concomitant treatment;
* Patient already included in another therapeutic trial;
* Metastatic disease (stage IVc);
* Pregnant woman, who may be pregnant, or currently breastfeeding;
* Persons deprived of liberty or under guardianship (including curatorship).

Where it's running

• Centre François Baclesse
  Caen, Caen, France Recruiting
• Institut de Cancérologie de Lorraine
  Vandœuvre-lès-Nancy, Grand Est, France Recruiting
• CHU Besançon
  Besançon, France Recruiting
• Centre Georges-François Leclerc
  Dijon, France Recruiting
• Intitut Jean Godinot
  Reims, France Recruiting
• Institut de Cancérologie Strasbourg Europe
  Strasbourg, France Recruiting

Study contacts

• Principal investigator: MARTZ NM Nicolas, MD. — Institut de Cancérologie de Lorraine
• Study coordinator: Jean-Louis JLM MERLIN, Pr
• Email: jl.merlin@nancy.unicancer.fr
• Phone: 03 83 59 83 07

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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.