NCT06479070Recrutement en cours
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.
Résumé
Squamous cell carcinomas of the upper aero-digestive tract (SCC-UADT) represent the seventh cause of cancer and affect approximately 600,000 patients per year worldwide. The majority of UADT cancers are diagnosed at an advanced stage (70.3% at stage III and IV) and less than 60% of these patients are free of the disease at 3 years, despite aggressive multimodal local treatment by surgery and /or radiochemotherapy. The average progression-free survival (PFS) at 2 years varies between 45 and 60% depending on the studies. Tumor recurrence is most often incurable. To our knowledge, no study has demonstrated the benefit of early evaluation of the rate of decrease in ctDNA at 1 month after the end of radiotherapy alone or associated with concomitant treatment, as a predictive factor of PFS in UADT squamous cell carcinomas regardless of their HPV status. The main objective of this study is to evaluate the value of measuring the quantity of circulating tumor DNA (ctDNA) at 1 month post-treatment as a predictive factor for PFS at 24 months.
Critères d'inclusion
• 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.
Critères d'exclusion
• 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).
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Sans phase (N/A)
- Type d'étude
- Interventionnelle
- Pays
- Suisse, France
- Promoteur
- Institut de Cancérologie de Lorraine(Autre)
- N° de protocole
- 2024-A00860-47
- Pathologies
- SCC - Squamous Cell Carcinoma, Upper Aero-digestive Tract (UADT) Neoplasm
- Interventions
- Autre
Traitements évalués
- Blood samples
Lieux · 7
- Zurich, SuisseUniversity Hospital Zurich (USZ)Recrute dans ce centre
- Caen, FranceCentre François BaclesseRecrute dans ce centre
- Vandœuvre-lès-Nancy, FranceInstitut de Cancérologie de LorraineRecrute dans ce centre
- Besançon, FranceCHU BesançonRecrute dans ce centre
- Dijon, FranceCentre Georges-François LeclercRecrute dans ce centre
- Reims, FranceIntitut Jean GodinotRecrute dans ce centre
- Strasbourg, FranceInstitut de Cancérologie Strasbourg EuropeRecrute dans ce centre
Au total, dans le monde, les 7 centres listés au registre recrutent.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 24 décembre 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.