RecruitingNot ApplicableNCT06479070

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.

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.

Sponsor

Institut de Cancérologie de Lorraine

Enrollment

188 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

SCC - Squamous Cell Carcinoma Upper Aero-digestive Tract (UADT) Neoplasm

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a blood test that detects tiny fragments of tumor DNA (ctDNA) can predict treatment outcomes for patients with head and neck cancers (affecting the mouth, throat, voicebox, and sinuses) receiving radiation therapy with or without chemotherapy. **You may be eligible if...** - You have newly diagnosed, confirmed squamous cell carcinoma of the head and neck (oral cavity, larynx, oropharynx, hypopharynx, or maxillary sinus) - Your cancer is stage III–IVb and non-metastatic - Your treatment plan (radiation with or without cisplatin or cetuximab) has been approved by a multidisciplinary team - Your performance status is adequate (ECOG/WHO 0–2) **You may NOT be eligible if...** - You have already received any treatment for this cancer - Your cancer has spread to distant organs - You are unable to give informed consent or complete study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood samples

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.