Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479070
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-24
Brief Title:
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
Sponsor:
Institut de Cancérologie de Lorraine
Organization:
Institut de Cancérologie de Lorraine
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRADOR
Brief Summary:
Squamous cell carcinomas of the upper aero-digestive tract SCC-UADT represent the seventh cause of cancer and affect approximately 600000 patients per year worldwide The majority of UADT cancers are diagnosed at an advanced stage 703 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
Detailed Description:
This is a prospective multicenter cohort study carried out on a total of 188 patients suffering from non-metastatic stage III and IV SCC-UADT oral cavity larynx oropharynx hypopharynx maxillary sinus naïve to any treatment during a consultation or day hospitalization during the radiotherapy consultation
The objective of the 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 This objective will be achieved by quantitatively measuring the number of copies of methylated ctDNA of genes of interest per mL of plasma This measurement of ctDNA will be evaluated by the rate of decrease in ctDNA between the centering scanner sample and 1 month post-treatment Two groups will be then considered patients with a reduction 85 and those with a reduction 85
In addition the interest of measuring the quantity of ctDNA at 1 month post-treatment as a predictive factor of overall survival OS and specific survival SS at 24 months the kinetics of the evolution of the quantities of ctDNA during the treatment and during follow-up up to 24 months and the evolution of ctDNA quantities during treatment and follow-up as a predictive factor for PFS and OS at 24 months will also be evaluated during this study The analyzes will be carried out in subgroups of populations according to their p16 status HPV viral protein and according to the presence or absence of concomitant treatment Cisplatin or Cetuximab
The objective of the 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 This objective will be achieved by quantitatively measuring the number of copies of methylated ctDNA of genes of interest per mL of plasma This measurement of ctDNA will be evaluated by the rate of decrease in ctDNA between the centering scanner sample and 1 month post-treatment Two groups will be then considered patients with a reduction 85 and those with a reduction 85
In addition the interest of measuring the quantity of ctDNA at 1 month post-treatment as a predictive factor of overall survival OS and specific survival SS at 24 months the kinetics of the evolution of the quantities of ctDNA during the treatment and during follow-up up to 24 months and the evolution of ctDNA quantities during treatment and follow-up as a predictive factor for PFS and OS at 24 months will also be evaluated during this study The analyzes will be carried out in subgroups of populations according to their p16 status HPV viral protein and according to the presence or absence of concomitant treatment Cisplatin or Cetuximab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None