Measuring circulating tumor DNA in patients with advanced upper aero-digestive tract cancer after radiotherapy
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.
This study is testing if measuring tumor DNA in the blood after radiation treatment can help predict how well patients with advanced throat and mouth cancer will do in the future.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Drugs / interventions | Cetuximab, immunotherapy |
| Locations | 7 sites (Caen, Caen and 6 other locations) |
| Trial ID | NCT06479070 on ClinicalTrials.gov |
What this trial studies
This study evaluates the prognostic value of circulating tumor DNA (ctDNA) levels in patients with stage III and IV squamous cell carcinoma of the upper aero-digestive tract who are undergoing curative radiotherapy. It involves a multicenter cohort of 188 patients who are newly diagnosed and treatment-naïve, measuring ctDNA levels at one month post-treatment to predict progression-free survival and overall survival at 24 months. The study will analyze the reduction in ctDNA levels and its correlation with patient outcomes, considering factors such as HPV status and treatment type.
Who should consider this trial
Good fit: Ideal candidates are adults with newly diagnosed, non-metastatic stage III or IV squamous cell carcinoma of the upper aero-digestive tract who have not received prior treatment.
Not a fit: Patients with metastatic disease or those with cancers located in areas other than the oral cavity, larynx, oropharynx, hypopharynx, and maxillary sinus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new predictive biomarker for patient outcomes in advanced upper aero-digestive tract cancer.
How similar studies have performed: While the approach of measuring ctDNA is gaining traction, this specific application in predicting outcomes for UADT cancers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Caen, Caen and 6 other locations
- Centre François Baclesse — Caen, Caen, France (Recruiting)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, Grand Est, France (Recruiting)
- CHU Besançon — Besançon, France (Recruiting)
- Centre Georges-François Leclerc — Dijon, France (Recruiting)
- Intitut Jean Godinot — Reims, France (Recruiting)
- Institut de Cancérologie Strasbourg Europe — Strasbourg, France (Recruiting)
- University Hospital Zurich (USZ) — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: MARTZ NM Nicolas, MD. — Institut de Cancérologie de Lorraine
- Study coordinator: Jean-Louis JLM MERLIN, Pr
- Email: jl.merlin@nancy.unicancer.fr
- Phone: 03 83 59 83 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.