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 ID: NCT06479070
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
188 participants
INTERVENTIONAL
2024-09-30
2029-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Interventional arm
12 blood samples will be taken from patients suffering from non-metastatic stage III and IV SCC-UADT (oral cavity, larynx, oropharynx, hypopharynx, maxillary sinus), naïve to any treatment
Blood samples
A blood sample of 20 mL (2 tubes of 10 mL) for research purposes will be collected during:
* The day of the centering scan (Visit 1);
* During treatment at Week 2 and Week 6 (+/- 1 week) (Visit 2 and 3);
* The day of the post-therapeutic visit scheduled between 3 and 5 weeks after the end of radiotherapy, whether or not associated with concomitant treatment (Visit 4);
* At each monitoring visit following radiotherapy associated or not with concomitant treatment (every 3 months for 24 months (V5 to V12 ; V12 = final visit)
* When the disease progresses before initiation of the 2nd line of treatment.
Interventions
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Blood samples
A blood sample of 20 mL (2 tubes of 10 mL) for research purposes will be collected during:
* The day of the centering scan (Visit 1);
* During treatment at Week 2 and Week 6 (+/- 1 week) (Visit 2 and 3);
* The day of the post-therapeutic visit scheduled between 3 and 5 weeks after the end of radiotherapy, whether or not associated with concomitant treatment (Visit 4);
* At each monitoring visit following radiotherapy associated or not with concomitant treatment (every 3 months for 24 months (V5 to V12 ; V12 = final visit)
* When the disease progresses before initiation of the 2nd line of treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Institut de Cancérologie de Lorraine
OTHER
Responsible Party
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Principal Investigators
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MARTZ NM Nicolas, MD.
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie de Lorraine
FAIVRE JCF Jean-Christophe, MD.
Role: STUDY_DIRECTOR
Institut de Cancérologie de Lorraine
Locations
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Centre François Baclesse
Caen, Caen, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Grand Est, 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, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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THARIAT TH Juliette, MD
Role: primary
MAMMARI HALABI NMH Nour, PhD.
Role: primary
CORROTTE CC CELINE
Role: primary
TIAGO ST Sandrine
Role: primary
MAUBERT ASM ANNE-SOPHIE
Role: primary
SARTORI VS VALERIE
Role: primary
BALERMPAS BP Pangiolis, PR
Role: primary
Lauer LD Debra
Role: backup
Other Identifiers
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2024-A00860-47
Identifier Type: -
Identifier Source: org_study_id