Detecting residual disease in advanced head and neck cancer using blood samples after radiotherapy
Prediction of Residual Disease by Circulating DNA Detection After Potentiated Radiotherapy for Locally Advanced Head and Neck Cancer
NA · Centre Jean Perrin · NCT05710679
This study is testing if analyzing blood samples can help find leftover cancer in patients with advanced head and neck cancer after they’ve had radiation treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Jean Perrin (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Clermont-Ferrand, Puy-de-Dôme and 2 other locations) |
| Trial ID | NCT05710679 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve the detection of residual disease in patients with locally advanced head and neck squamous cell carcinoma (HNSCC) following potentiated radiotherapy. By analyzing circulating DNA from blood samples, the study seeks to provide a more sensitive and reliable method for assessing treatment outcomes compared to traditional imaging techniques. The trial will include patients aged 18 to 80 with specific types of HNSCC and will evaluate the effectiveness of this blood-based approach in predicting residual disease. The ultimate goal is to enhance patient management and treatment strategies for this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with untreated, histologically confirmed locally advanced head and neck squamous cell carcinoma involving lymph nodes.
Not a fit: Patients with nasopharyngeal tumors, metastatic disease, or those who have received prior treatment for head and neck cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate assessments of treatment response, potentially improving patient outcomes and reducing unnecessary surgeries.
How similar studies have performed: While the approach of using circulating DNA for disease detection is gaining traction, this specific methodology in the context of advanced HNSCC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clermont-Ferrand, Puy-de-Dôme and 2 other locations
- Centre Jean PERRIN — Clermont-Ferrand, Puy-de-Dôme, France (RECRUITING)
- Hôpital de la Croix-Rousse — Lyon, France (RECRUITING)
- CHU de Saint-Étienne — Saint-Etienne, France (RECRUITING)
Study contacts
- Principal investigator: Maureen BERNADACH, MD — Centre Jean Perrin
- Study coordinator: Angeline GINZAC COUVÉ, PhD
- Email: angeline.ginzac@clermont.unicancer.fr
- Phone: 0463663337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Head and Neck Carcinoma