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.
Institut de Cancérologie de Lorraine
188 participants
Sep 30, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- OMS 0 to 2;
- Patient suffering from UADT squamous cell carcinoma, newly diagnosed and histologically proven, regardless of the p16 protein status, naïve to any treatment for this cancer;
- Non-metastatic cancer of stages III (N1), IVa (N1 minimum) or IVb;
- Cancer localized in the oral cavity, larynx, oropharynx, hypopharynx and maxillary sinus;
- Patient for whom treatment with curative radiotherapy associated or not with concomitant treatment (Cisplatin or Cetuximab) has been validated in a multidisciplinary consultation meeting (RCP);
- Patient capable and willing to follow all study procedures in accordance with the protocol;
- Patient having understood, signed and dated the consent form communicated on the day of inclusion;
- Patient affiliated to the social security system.
Exclusion Criteria11
- Minor patient;
- Cancer located in the cavum, ethmoidal sinus, salivary glands and skin (cutaneous squamous cell carcinoma);
- Patient already treated for UADT tumor;
- Patient treated with immunotherapy;
- Patient who has already had cancer within 5 years (cancer other than in the UADT sphere);
- OMS \> 2;
- Contraindication to radiotherapy treatment associated or not with concomitant treatment;
- Patient already included in another therapeutic trial;
- Metastatic disease (stage IVc);
- Pregnant woman, who may be pregnant, or currently breastfeeding;
- Persons deprived of liberty or under guardianship (including curatorship).
Interventions
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.
Locations(7)
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NCT06479070