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.

NCT06479070 | Recruiting

• 1 other identifier: 2024-A00860-47
• Study Type: interventional
• Target: 188
• Locations: 2 countries
• Sites: 7

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

Keywords

Squamous Cell Carcinoma; upper aero-digestive trac tumor; Ct DNA; Radiotherapy; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

  At 1 month post-treatment

• Study the kinetics of the evolution of ctDNA quantities during treatment and during follow-up up to 24 months.

  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.

  At 24 months.

• Evaluate the discriminatory capacity of ctDNA at 1 month post-treatment to predict response to treatment at 24 months.

  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%.

  1 month.

Study Arms (1)

Interventional arm

OTHER

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

Other: Blood samples

Interventions

Blood samples OTHER

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.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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).

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (7)

Centre François Baclesse

Caen, Caen, 14076, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Grand Est, 54500, France

RECRUITING

CHU Besançon

Besançon, 25030, France

RECRUITING

Centre Georges-François Leclerc

Dijon, 21000, France

RECRUITING

Intitut Jean Godinot

Reims, 51100, France

RECRUITING

Institut de Cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

University Hospital Zurich (USZ)

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Neoplasms; Head and Neck Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• MARTZ NM Nicolas, MD.

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• FAIVRE JCF Jean-Christophe, MD.

  Institut de Cancérologie de Lorraine

  STUDY DIRECTOR

Central Study Contacts

Jean-Louis JLM MERLIN, Pr

CONTACT

03 83 59 83 07; jl.merlin@nancy.unicancer.fr

MARTZ NM Nicolas, MD.

CONTACT

n.martz@nancy.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohorte, prospective and multicenter study.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); CH (1)