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.
NCT Number: NCT06479070
Acronym: CIRADOR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: SCC - Squamous Cell Carcinoma|Upper Aero-digestive Tract (UADT) Neoplasm
Interventions: OTHER: Blood samples
Sponsor: Institut de Cancérologie de Lorraine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 188
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-09-01
Completion Date: 2029-09-01
Locations: Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, Grand-Est, 54500, France|CHU Besançon, Besançon, 25030, France|Centre Georges-François Leclerc, Dijon, 21000, France|Intitut Jean Godinot, Reims, 51100, France|Institut de Cancérologie Strasbourg Europe, Strasbourg, 67033, France

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.

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., 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., At 1 month post-treatment
Secondary Outcome Measures: Evaluate the value of measuring the quantity of ctDNA at 1 month post-treatment as a predictive factor for overall survival and specific survival at 24 months., ctDNA will be measured quantitatively as the number of copies of methylated tcDNA of the genes of interest per mL of plasma., At 1 month post-treatment|Study the kinetics of the evolution of ctDNA quantities during treatment and during follow-up up to 24 months., Overall survival is defined by the time elapsed between the date of end of treatment and the date of death from all causes., During treatment and follow-up up to 24 months.|Evaluate the evolution of ctDNA quantities during treatment and follow-up as a predictive factor for progression-free survival and overall survival at 24 months., Specific survival is defined by the time elapsed between the date of end of treatment and the date of cancer-related death., At 24 months.|Evaluate the discriminatory capacity of ctDNA at 1 month post-treatment to predict response to treatment at 24 months., The kinetics of the evolution of the quantity of ctDNA will be studied from pre-treatment, during treatment and up to 24 months of post-treatment follow-up., At 1 month post-treatment|Compare the clinico-pathological characteristics according to the 2 defined groups: patients with a ≥ 85% decrease in ctDNA between the centration scanner sample and the sample at 1 month post-treatment and those with a decrease <85%., The evolution of the quantities of ctDNA before treatment, during treatment and up to 24 months of post-treatment follow-up will be evaluated as a risk factor for progression-free survival and overall survival at 24 months., 1 month.|Analyze the populations into subgroups according to their p16 status (HPV viral protein) and according to the presence or absence of concomitant treatment (Cisplatin or Cetuximab)., Evaluation of partial or complete response to treatment at the last clinical evaluation at 24 months post-treatment by clinical and radiological data., at 24 months post-treatment.