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.
Recruiting now · Not applicable
Conditions studied: SCC - Squamous Cell Carcinoma, Upper Aero-digestive Tract (UADT) Neoplasm
In brief
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.
Key facts
- Study ID
- NCT06479070
- Run by
- Institut de Cancérologie de Lorraine
- People needed
- 188
- Starts
- 2024-09-30
- Expected to finish
- 2029-09-30
- Last updated by the study team
- 2025-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Centre François Baclesse — Caen, Caen, France (enrolling)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, Grand Est, France (enrolling)
- CHU Besançon — Besançon, France (enrolling)
- Centre Georges-François Leclerc — Dijon, France (enrolling)
- Intitut Jean Godinot — Reims, France (enrolling)
- Institut de Cancérologie Strasbourg Europe — Strasbourg, France (enrolling)
- University Hospital Zurich (USZ) — Zurich, Canton of Zurich, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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