Prognostic Value of Measuring CtDNA in a Cohort of Patients With Stage III and IV Upper Aero-digestive Tract (UADT) Cancer , Treated With Curative RADiOtherapy With or Without Concomitant Treatment.

Launched by INSTITUT DE CANCÉROLOGIE DE LORRAINE · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the role of a special type of DNA called circulating tumor DNA (ctDNA) in patients with advanced squamous cell carcinoma of the upper aero-digestive tract (UADT) who are receiving treatment with radiation therapy. The researchers want to find out if measuring the amount of ctDNA one month after treatment can help predict how long patients will live without their cancer returning, known as progression-free survival, over a period of 24 months. This is important because many patients with UADT cancers do not do well long-term, and finding better ways to monitor their disease could improve outcomes.

To be eligible for this trial, participants must be adults between 65 and 74 years old, newly diagnosed with non-metastatic stage III or IV UADT squamous cell carcinoma, and have not received any prior treatment for their cancer. They also need to be able to follow the study procedures and provide informed consent. If someone joins the trial, they can expect to undergo regular assessments to measure ctDNA levels after their treatment. This study is currently recruiting participants, and those who qualify will receive close monitoring and care as part of the trial.

Gender

ALL

Eligibility criteria

• • 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).