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Studies

Interventional Recruiting

NCT06479070 on ClinicalTrials.gov

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.

Official title: Prognostic Value of Measuring Circulating Tumor DNA in a Cohort of Patients With Stage III and IV UADT Cancer, Treated With Curative RADiOtherapy With or Without Concomitant Treatment.

  • Sponsor: Institut de Cancérologie de Lorraine
  • Enrollment: 188 (Estimated)
  • Study start: 2024-09-30 (Actual)
  • Primary completion: 2026-09-30 (Estimated)
  • Study completion: 2029-09-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: Cohorte, prospective and multicenter study.
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • SCC - Squamous Cell Carcinoma
  • Upper Aero-digestive Tract (UADT) Neoplasm

Intervention / Treatment

  • Other: Blood samples

Primary Outcome Measures

  • To evaluate the value of measuring the quantity of circulating tumor DNA (tcDNA) at 1 month post-treatment as a predictive factor for progression-free survival at 24 months. (At 1 month post-treatment)
    ctDNA will be measured quantitatively as the number of copies of methylated ctDNA of the genes of interest per mL of plasma. The ctDNA measurement will be evaluated by the rate of decrease in ctDNA between the centering scanner sample and 1 month post-treatment. Two groups will then be considered: patients with a reduction ≥ 85% and those with a reduction \< 85%. Progression-free survival is defined by the time elapsed between the date of end of treatment (radiotherapy associated or not with concomitant treatment) and the onset of disease progression or death from all causes.

Countries

France, Switzerland

Locations and Investigators

  • Centre François Baclesse, Caen, France (Recruiting)
  • Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France (Recruiting)
    • MAMMARI HALABI NMH Nour, PhD.
    • MARTZ NM Nicolas, MD. (Principal Investigator)
  • CHU Besançon, Besançon, France (Recruiting)
    • CORROTTE CC CELINE
    • BOUSTANI JB JIHANE, MD.
  • Centre Georges-François Leclerc, Dijon, France (Recruiting)
    • TIAGO ST Sandrine
    • TRUC GT GILLES, MD.
  • Intitut Jean Godinot, Reims, France (Recruiting)
    • MAUBERT ASM ANNE-SOPHIE
    • BEDDOK AB Arnaud, MD.
  • Institut de Cancérologie Strasbourg Europe, Strasbourg, France (Recruiting)
    • SARTORI VS VALERIE
    • BRAHIMI YB Youssef, MD.
  • University Hospital Zurich (USZ), Zurich, Switzerland (Recruiting)
    • BALERMPAS BP Pangiolis, PR
    • Lauer LD Debra
    • BALERMPAS BP Pangiolis, MD. (Principal Investigator)

Study Officials