RecruitingNot Applicable

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.

France, Switzerland188 participantsStarted 2024-09-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the value of measuring the quantity of circulating tumor DNA (tcDNA) at 1 month post-treatment as a predictive factor for progression-free survival at 24 months.

Timeframe: At 1 month post-treatment

Trial details

NCT IDNCT06479070

SponsorInstitut de Cancérologie de Lorraine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Jean-Louis JLM MERLIN, Pr

03 83 59 83 07 jl.merlin@nancy.unicancer.fr

View on ClinicalTrials.gov More SCC - Squamous Cell Carcinoma trials