NCT05710679 Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer
| NCT ID | NCT05710679 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Jean Perrin |
| Condition | Locally Advanced Head and Neck Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 63 participants |
| Start Date | 2024-01-17 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 63 participants in total. It began in 2024-01-17 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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%. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
Contact & Investigator
Maureen BERNADACH, MD
PRINCIPAL INVESTIGATOR
Centre Jean Perrin
Frequently Asked Questions
Who can join the NCT05710679 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Locally Advanced Head and Neck Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05710679 currently recruiting?
Yes, NCT05710679 is actively recruiting participants. Contact the research team at angeline.ginzac@clermont.unicancer.fr for enrollment information.
Where is the NCT05710679 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France, Aurillac, France, Lyon, France, Saint-Etienne, France.
Who is sponsoring the NCT05710679 clinical trial?
NCT05710679 is sponsored by Centre Jean Perrin. The principal investigator is Maureen BERNADACH, MD at Centre Jean Perrin. The trial plans to enroll 63 participants.