SCC - Squamous Cell CarcinomaCIRADORNCT06479070
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.
A study testing Blood samples in people with SCC - Squamous Cell Carcinoma and Upper Aero-digestive Tract (UADT) Neoplasm, run by Institut de Cancérologie de Lorraine at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCC - Squamous Cell Carcinoma, Upper Aero-digestive Tract (UADT) Neoplasm
- What is being tested?
- Blood samples
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 30 Sep 2024to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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).
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
MARTZ NM Nicolas, MD. contact
7 sites in 2 countries
France6 sites, 6 recruiting
- Recruiting
CHU Besançon
Besançon, 25030
CORROTTE CC CELINE, 03 70 63 20 65, ccorrotte@chu-besancon.fr
BOUSTANI JB JIHANE, MD.
- Recruiting
Centre François Baclesse
Caen, Caen, 14076
THARIAT TH Juliette, MD, 02 31 45 50 50, jthariat@gmail.com
- Recruiting
Centre Georges-François Leclerc
Dijon, 21000
TIAGO ST Sandrine, 03 80 73 75 00, stiago@cgfl.fr
TRUC GT GILLES, MD.
- Recruiting
Intitut Jean Godinot
Reims, 51100
MAUBERT ASM ANNE-SOPHIE, 03 26 50 41 84, annesophie.maubert@reims.unicancer.fr
BEDDOK AB Arnaud, MD.
- Recruiting
Institut de Cancérologie Strasbourg Europe
Strasbourg, 67033
SARTORI VS VALERIE, 03 68 76 72 23, v.sartori@icans.eu
BRAHIMI YB Youssef, MD.
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Grand Est, 54500
MAMMARI HALABI NMH Nour, PhD., 0383598455, n.mammarihalabi@nancy.unicancer.fr
MARTZ NM Nicolas, MD.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich (USZ)
Zurich, Canton of Zurich, 8091
BALERMPAS BP Pangiolis, PR, +41 43 253 28 17, Panagiotis.Balermpas@usz.ch
Lauer LD Debra, +41 43 253 28 17, Debra.Lauer@usz.ch
About this study
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.
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.
Read the 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).
- Being tested
- Blood samples
- Keywords
- Squamous Cell Carcinoma, upper aero-digestive trac tumor, Ct DNA, Radiotherapy, Head and neck cancer
- Medical subject headings
- Carcinoma, Squamous Cell, Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
ctDNA will be measured quantitatively as the number of copies of methylated tcDNA of the genes of interest per mL of plasma.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 24 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start30 Sep 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCC - Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohorte, prospective and multicenter study.
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MARTZ NM Nicolas, MD., Principal investigator, Institut de Cancérologie de LorraineFAIVRE JCF Jean-Christophe, MD., Study director, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479070
- Sponsor's protocol ID
- 2024-A00860-47
- Acronym
- CIRADOR
- Status last verified
- Dec 2025
- First submitted
- 24 Jun 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigator centers responded to a feasibility questionnaire. After their agreement, they have access to the protocol, the synopsis and all the study documents as well as the eCRF for data entry.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06479070
- Acronym / sponsor ID
- CIRADOR / 2024-A00860-47
- Keywords
- Squamous Cell Carcinoma, upper aero-digestive trac tumor, Ct DNA, Radiotherapy, Head and neck cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohorte, prospective and multicenter study.
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Other | Other: Blood samples12 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesA 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. | Other | Interventional arm |
Primary outcome
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.
6 secondary outcomes
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
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.
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.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No. The investigator centers responded to a feasibility questionnaire. After their agreement, they have access to the protocol, the synopsis and all the study documents as well as the eCRF for data entry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MARTZ NM Nicolas, MD. contact
MARTZ NM Nicolas, MD. principal investigator
Institut de Cancérologie de Lorraine
FAIVRE JCF Jean-Christophe, MD. study director
Institut de Cancérologie de Lorraine
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with SCC - Squamous Cell Carcinoma and Upper Aero-digestive Tract (UADT) Neoplasm, run by Institut de Cancérologie de Lorraine at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Louis JLM MERLIN, Pr (03 83 59 83 07, jl.merlin@nancy.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.