Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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.

Led by Institut de Cancérologie de Lorraine · Updated on 2025-12-24

188

Participants Needed

7

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Newly diagnosed and histologically confirmed squamous cell carcinoma of the upper aero-digestive tract
  • Non-metastatic stage III (N1), IVa (N1 minimum), or IVb cancer
  • Cancer located in the oral cavity, larynx, oropharynx, hypopharynx, or maxillary sinus
  • Planned treatment with curative radiotherapy with or without concomitant Cisplatin or Cetuximab
  • Able and willing to follow all study procedures
  • Provided signed informed consent
  • Affiliated with the social security system
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Cancer located in the cavum, ethmoidal sinus, salivary glands, or skin (cutaneous squamous cell carcinoma)
  • Previously treated for upper aero-digestive tract tumor
  • Treated with immunotherapy
  • History of other cancers within the past 5 years (outside of UADT)
  • Performance status greater than 2
  • Contraindications to radiotherapy or concomitant treatment
  • Currently enrolled in another therapeutic trial
  • Metastatic disease (stage IVc)
  • Pregnant, possibly pregnant, or breastfeeding
  • Under legal guardianship or deprived of liberty

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Centre François Baclesse

Caen, Caen, France, 14076

Actively Recruiting

2

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Grand Est, France, 54500

Actively Recruiting

3

CHU Besançon

Besançon, France, 25030

Actively Recruiting

4

Centre Georges-François Leclerc

Dijon, France, 21000

Actively Recruiting

5

Intitut Jean Godinot

Reims, France, 51100

Actively Recruiting

6

Institut de Cancérologie Strasbourg Europe

Strasbourg, France, 67033

Actively Recruiting

7

University Hospital Zurich (USZ)

Zurich, Canton of Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

J

Jean-Louis JLM MERLIN, Pr

CONTACT

M

MARTZ NM Nicolas, MD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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