Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer

Trial Title: Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer

NCT ID: NCT05710679

Condition: Locally Advanced Head and Neck Carcinoma

Conditions: Official terms:
Head and Neck Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Biological samples of patients included in the study (i.e., patients treated with potentiated radiotherapy 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 potentiated radiotherapy will undergone a salvage adenectomy. The main objective is to assess the ability of circulating DNA to predict residual disease during salvage adenectomy.

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Blood sample
Description: The intervention consist in a blood sample that will be taken twice : - at the inclusion (before treatment) - 3 months after the potentiated radiotherapy in case of incomplete response (PET-CT)
Arm group label: Interventional

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.

Criteria for 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, IVa or IVb, N1 minimum, resectable but not operated or unresectable, with indication for potentiated radiotherapy - 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Centre Jean PERRIN

Address:
City: Clermont-Ferrand
Zip: 63011
Country: France

Status: Recruiting

Contact:
Last name: Angeline GINZAC COUVÉ
Email: angeline.ginzac@clermont.unicancer.fr

Contact backup:
Last name: Maureen BERNADACH, Dr

Facility:
Name: CHU de Grenoble Alpes

Address:
City: Grenoble
Country: France

Status: Not yet recruiting

Contact:
Last name: Christian RIGHINI, Pr

Facility:
Name: Hôpital de la Croix-Rousse

Address:
City: Lyon
Country: France

Status: Recruiting

Contact:
Last name: Philippe CÉRUSE, Pr

Facility:
Name: CHU de Saint-Étienne

Address:
City: Saint-Étienne
Country: France

Status: Not yet recruiting

Contact:
Last name: Yann LELONGE, Dr

Start date: January 17, 2024

Completion date: July 2030

Lead sponsor:
Agency: Centre Jean Perrin
Agency class: Other

Collaborator:
Agency: Groupement Inter-Régional de Recherche Clinique et d'Innovation Auvergne Rhône-Alpes
Agency class: Other

Source: Centre Jean Perrin

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05710679