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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.

RecruitingNAAges 18 Years - anyAllInstitut de Cancérologie de Lorraine
NCT06479070 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 e

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📋 Eligibility rules (as published)
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).
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What it tests

  • Blood samples
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Where

7 sites
Centre François Baclesse
Caen, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
CHU Besançon
Besançon, France
Centre Georges-François Leclerc
Dijon, France
Intitut Jean Godinot
Reims, France
Institut de Cancérologie Strasbourg Europe
Strasbourg, France
University Hospital Zurich (USZ)
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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