NCT06479070 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.
| NCT ID | NCT06479070 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut de Cancérologie de Lorraine |
| Condition | SCC - Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2026-09-30 |
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 188 participants in total. It began in 2024-09-30 with a primary completion date of 2026-09-30.
⚠ 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
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 Criteria
Inclusion Criteria * 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 Criteria: * 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).
Contact & Investigator
MARTZ NM Nicolas, MD.
PRINCIPAL INVESTIGATOR
Institut de Cancérologie de Lorraine
Frequently Asked Questions
Who can join the NCT06479070 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SCC - Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06479070 currently recruiting?
Yes, NCT06479070 is actively recruiting participants. Contact the research team at jl.merlin@nancy.unicancer.fr for enrollment information.
Where is the NCT06479070 trial being conducted?
This trial is being conducted at Caen, France, Vandœuvre-lès-Nancy, France, Besançon, France, Dijon, France and 3 additional locations.
Who is sponsoring the NCT06479070 clinical trial?
NCT06479070 is sponsored by Institut de Cancérologie de Lorraine. The principal investigator is MARTZ NM Nicolas, MD. at Institut de Cancérologie de Lorraine. The trial plans to enroll 188 participants.