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NCT Number: NCT06479070

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.

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.

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Key information

Conditions

SCC - Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Upper Aero-digestive Tract (UADT) Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 having understood, signed and dated the consent form communicated on the day of inclusion;
  • Patient affiliated to the social security system.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

    Time frame: 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.

Secondary outcomes

  1. 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.

    Time frame: At 1 month post-treatment

    ctDNA will be measured quantitatively as the number of copies of methylated tcDNA of the genes of interest per mL of plasma.

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

    Time frame: During treatment and 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.

  3. 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.

    Time frame: 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.

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

    Time frame: At 1 month post-treatment

    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.

  5. 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%.

    Time frame: 1 month.

    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.

  6. 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).

    Time frame: at 24 months post-treatment.

    Evaluation of partial or complete response to treatment at the last clinical evaluation at 24 months post-treatment by clinical and radiological data.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-Louis JLM MERLIN, Pr

CONTACT

[email protected]

03 83 59 83 07

MARTZ NM Nicolas, MD.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study 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.

Acronym: CIRADOR

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jun 27, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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