Locally Advanced Head and Neck CarcinomaNeckTARNCT05710679
Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer
A study testing Blood sample in people with Locally Advanced Head and Neck Carcinoma, run by Centre Jean Perrin at 4 sites in France.
Trial summary
Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Head and Neck Carcinoma
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Jan 2024to Jul 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years
- Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement
- squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)
- Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary
- Availability of FFPE samples prior to treatment initiation
- Detection of circulating DNA in the initial blood sample
- Obtaining informed consent from the patient
- Affiliation to the French social security system
Who cannot join
- Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer
- Treatment by exclusive radiotherapy
- Contraindication to cervical lymph node dissection
- Metastatic disease (stage IVc)
- Previous treatment for head and neck cancer
- History of other cancer in the last 3 years (except carcinoma in situ, basal cell skin carcinoma, localized prostate cancer Gleason 6)
Show all 9Show fewer
- Pregnant or breastfeeding woman
- Patient under guardianship or curators
- Psychological disorder (cognitive disorders, vigilance disorders, etc.) or social reasons (deprivation of liberty by judicial or administrative decision) or geographical reasons that could compromise the medical follow-up of the trial or compliance with the treatment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Henri Mondor
Aurillac, 15000
Daniela BURLACU, MD, 0471465656, D.burlacu@ch-aurillac.fr
- Recruiting
Centre Jean PERRIN
Clermont-Ferrand, Puy-de-Dôme, 63011
Angeline GINZAC COUVÉ, angeline.ginzac@clermont.unicancer.fr
Maureen BERNADACH, Dr
- Recruiting
Hôpital de la Croix-Rousse
Lyon
Philippe CÉRUSE, Pr
- Recruiting
CHU de Saint-Étienne
Saint-Etienne
Yann LELONGE, Dr
About this study
Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.
18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET/CT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.
Read more
Circulating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.
This is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.
- Conditions
- Locally Advanced Head and Neck Carcinoma
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
The intervention consist in a blood sample that will be taken twice :
- at the inclusion (before treatment)
- 3 months after the radiochemotherapy in case of incomplete response (PET-CT)
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Not described Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with incomplete cervical lymph node response on PET-CT after radiochemotherapy having circulating DNA (cDNA)
Presence/absence of circulating DNA after treatment versus presence/absence of residual disease
Measured: 3 months after potentiated radiotherapy
Secondary outcomes (8)
cDNA detection rate among patients with residual adenomegaly after treatment
The detection of cDNA and response on CT-Scan will be compared
Measured: at three-months after potentiated radiotherapy.
Assessment of the prognostic value of cDNA detection 3 months after the end of radiochemotherapy for patients with residual adenomegaly
Evaluated by overall and progression-free survival
Measured: at three-months after potentiated radiotherapy.
Assessment of the prognosis value of the presence of residual adenomegaly
Evaluated by overall and progression-free survival
Measured: At month 27
Rate of concordance of mutational profiles and Human papillomavirus-high risk (HPV-HR) genotypes between the primary tumor and cDNAs at diagnosis
evaluated the mutational profiles from FFPE block and the inclusion blood sample
Measured: Inclusion
Rate of concordance between p16 immunohistochemistry and HPV-HR genotyping on the primary tumor
Measured: Inclusion
Test of the concordance between real-time polymerase chain reaction (PCR) and NGS on formalin-fixed paraffin-embedded (FFPE) for simultaneous detection and genotyping of HPV-HR at diagnosis
Measured: Inclusion
Number of patients with ctDNA and cvDNA detection at diagnosis and the clinical, paraclinical and pathological features of the cancer
Measured: Through study completion, an average of 66 months
Evaluation of interobserver reproducibility of the interpretation of SUVmax measurements of residual cervical adenomegaly.
A centralized review of the PET-CT will be done by the sponsor to evaluate the reproducibility of the interpretation of SUVmax measurements of residual cervixal adenomegaly (pathological/benign/equivocal)
Measured: 3 months after potentiated radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start17 Jan 2024
- Primary completionApr 2029 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Head and Neck 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
- Biological samples of patients included in the study (i.e., patients treated with radiochemotherapy for a locally advanced head and neck cancer) will be analysed (Next generation sequencing (NGS)): * At inclusion : a FFPE block + a blood sample to identify tumor specific variants (tcDNA and cvDNA) * 3 months after radiotherapy in case of incomplete response (PET-CT) : a blood sample to search if the tumor specific variants identified before the treatment are found Patients with incomplete response after 3 months radiochemotherapy will undergone a salvage adenectomy. The main objective is to assess the ability of circulating DNA to predict residual disease during salvage adenectomy.
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes
- Responsible party
- Sponsor
- Investigators
- Maureen BERNADACH, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710679
- Sponsor's protocol ID
- 2022-A01668-35
- Acronym
- NeckTAR
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ginzac A, Ferreira MC, Cayre A, Bouvet C, Biau J, Molnar I, Saroul N, Pham-Dang N, Durando X, Bernadach M. Prediction of residual disease using circulating DNA detection after potentiated radiotherapy for locally advanced head and neck cancer (NeckTAR): a study protocol for a prospective, multicentre trial. BMC Cancer. 2023 Jul 4;23(1):621. doi: 10.1186/s12885-023-11136-2.
PubMed 37400806
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05710679
- Acronym / sponsor ID
- NeckTAR / 2022-A01668-35
- Conditions
- Locally Advanced Head and Neck Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 2 Feb 2023 (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.
Sixty percent of newly diagnosed head and neck squamous cell carcinomas (HNSCCs) are at a locally advanced (LA) stage. Depending on tumor site, stage, and resectability, locoregional failure rates can range from 35% to 65%. The persistence of residual disease at the end of treatment is a major prognostic element but is not always reliably assessed by current imaging techniques. Up to 40-50% of patients have residual adenomegaly and only 30% have viable disease when further adenectomy is performed. Sensitive and reproducible detection of residual disease after treatment is a major challenge in this patient category.
18F-fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET/CT) guided surveillance, with a negative predictive value of 95-97%, has proven to be non-inferior to cervical curage in HNSCCs with residual adenomegaly. Cervical curage is now indicated only if the response assessed by PET-CT is incomplete. Nevertheless, the ability of PET-CT to predict treatment failure is unsatisfactory due to a high frequency of false positives, because of inflammatory changes, with a positive predictive value of about 20-50%.
Circulating tumor DNA (ctDNA) may provide a more reliable assessment of response to potentiated radiotherapy. Liquid biopsy monitoring of response in patients treated with potentiated radiation therapy for locally advanced HNSCCs a has been shown to be feasible. In 85% of patients, ctDNA is detectable and correlates significantly with tumor volume and response to treatment. In addition, one study showed that post-radiotherapy analysis of circulating HPV16 viral DNA (cvDNA) in patients with HPV16-related HNSCCs complemented PET-CT and helped guide management decisions. HPV16 cvDNA and PET-CT have similar negative predictive values, whereas the positive predictive value is higher for HPV16 cvDNA (100% versus 50%). Nevertheless, current data are insufficient to allow routine use of this marker.
This is a multicenter, single arm, open study for patients with a locally advanced head and neck cancer for which a potentiated radiotherapy is indicated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biological samples of patients included in the study (i.e., patients treated with radiochemotherapy for a locally advanced head and neck cancer) will be analysed (Next generation sequencing (NGS)): * At inclusion : a FFPE block + a blood sample to identify tumor specific variants (tcDNA and cvDNA) * 3 months after radiotherapy in case of incomplete response (PET-CT) : a blood sample to search if the tumor specific variants identified before the treatment are found Patients with incomplete response after 3 months radiochemotherapy will undergone a salvage adenectomy. The main objective is to assess the ability of circulating DNA to predict residual disease during salvage adenectomy.
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Biological: Blood sample |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≤ 80 years
- Histologically confirmed, never treated squamous cell carcinoma with lymph node involvement
- squamous cell carcinoma p16+or p16-, stage III (N1), IVa or IVb (UICC classification 8th edition), N1 minimum, and oropharyngeal sqamous cell carcinomas p16+ stage I or II, N1 minimum, resectable but not operated or unresectable, with indication for concomitant or sequential radiochemotherapy with induction chemotherapy using Docetaxel, Platinum, 5-Fluorouracil (TPF or modified TPF according to the practices of the investigating centers)
- Oral cavity, oropharynx, hypopharynx or larynx, cervical adenopathies without primary
- Availability of FFPE samples prior to treatment initiation
Key exclusion criteria (9 listed)
- Tumor of the nasopharynx, sinuses, nasal cavity, salivary glands or thyroid cancer
- Treatment by exclusive radiotherapy
- Contraindication to cervical lymph node dissection
- Metastatic disease (stage IVc)
- Previous treatment for head and neck cancer
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 sampleThe intervention consist in a blood sample that will be taken twice : * at the inclusion (before treatment) * 3 months after the radiochemotherapy in case of incomplete response (PET-CT) | Biological | Interventional |
Primary outcome
Rate of patients with incomplete cervical lymph node response on PET-CT after radiochemotherapy having circulating DNA (cDNA)
Time frame: 3 months after potentiated radiotherapy
Presence/absence of circulating DNA after treatment versus presence/absence of residual disease
8 secondary outcomes
cDNA detection rate among patients with residual adenomegaly after treatment
Time frame: at three-months after potentiated radiotherapy.
Assessment of the prognostic value of cDNA detection 3 months after the end of radiochemotherapy for patients with residual adenomegaly
Time frame: at three-months after potentiated radiotherapy.
Assessment of the prognosis value of the presence of residual adenomegaly
Time frame: At month 27
Rate of concordance of mutational profiles and Human papillomavirus-high risk (HPV-HR) genotypes between the primary tumor and cDNAs at diagnosis
Time frame: Inclusion
Rate of concordance between p16 immunohistochemistry and HPV-HR genotyping on the primary tumor
Time frame: Inclusion
Test of the concordance between real-time polymerase chain reaction (PCR) and NGS on formalin-fixed paraffin-embedded (FFPE) for simultaneous detection and genotyping of HPV-HR at diagnosis
Time frame: Inclusion
Number of patients with ctDNA and cvDNA detection at diagnosis and the clinical, paraclinical and pathological features of the cancer
Time frame: Through study completion, an average of 66 months
Evaluation of interobserver reproducibility of the interpretation of SUVmax measurements of residual cervical adenomegaly.
Time frame: 3 months after potentiated radiotherapy
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 11 Sep 2026.
- Background: PubMed 37400806Ginzac A, Ferreira MC, Cayre A, Bouvet C, Biau J, Molnar I, Saroul N, Pham-Dang N, Durando X, Bernadach M. Prediction of residual disease using circulating DNA detection after potentiated radiotherapy for locally advanced head and neck cancer (NeckTAR): a study protocol for a prospective, multicentre trial. BMC Cancer. 2023 Jul 4;23(1):621. doi: 10.1186/s12885-023-11136-2.
Related trials for Locally Advanced Head and Neck Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruitingPhase 1/2
Intravenously Administered PROMITIL Combined With Radiotherapy in Patients With Cisplatin-Ineligible Head and Neck Cancer Patients
Head & Neck Squamous Cell Carcinoma, Locally Advanced Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 2
Soylent in Reducing Gastrostomy Tube Rates in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiotherapy
Locally Advanced Head and Neck Carcinoma
Not yet recruitingPhase 2
Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
Squamous Cell Carcinoma of Head and Neck (SCCHN)
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.
Maureen BERNADACH, MD principal investigator
Centre Jean Perrin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Locally Advanced Head and Neck Carcinoma, run by Centre Jean Perrin at 4 sites in France.
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 9 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 Angeline GINZAC COUVÉ, PhD (0463663337 ext. +33, angeline.ginzac@clermont.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with incomplete cervical lymph node response on PET-CT after radiochemotherapy having circulating DNA (cDNA) (time frame: 3 months after potentiated radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710679, which also lists 1 linked publication.
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 11 Sep 2026.