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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut de Cancérologie de Lorraine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood samples

    Other intervention

    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.

Treatment groups

188 Participants
are divided into 1 treatment group
Group A: Interventional armOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

ctDNA will be measured quantitatively as the number of copies of methylated ctDNA of the genes of interest per mL of plasma. The ctDNA measurement will be evaluated by the rate of decrease in ctDNA between the centering scanner sample and 1 month post-treatment. Two groups will then be considered: patients with a reduction ≥ 85% and those with a reduction \< 85%. Progression-free survival is defined by the time elapsed between the date of end of treatment (radiotherapy associated or not with concomitant treatment) and the onset of disease progression or death from all causes.

Time frame
At 1 month post-treatment

Secondary outcomes

1

Evaluate the value of measuring the quantity of ctDNA at 1 month post-treatment as a predictive factor for overall survival and specific survival at 24 months.

ctDNA will be measured quantitatively as the number of copies of methylated tcDNA of the genes of interest per mL of plasma.

Time frame
At 1 month post-treatment
2

Study the kinetics of the evolution of ctDNA quantities during treatment and during follow-up up to 24 months.

Overall survival is defined by the time elapsed between the date of end of treatment and the date of death from all causes.

Time frame
During treatment and follow-up up to 24 months.
3

Evaluate the evolution of ctDNA quantities during treatment and follow-up as a predictive factor for progression-free survival and overall survival at 24 months.

Specific survival is defined by the time elapsed between the date of end of treatment and the date of cancer-related death.

Time frame
At 24 months.
4

Evaluate the discriminatory capacity of ctDNA at 1 month post-treatment to predict response to treatment at 24 months.

The kinetics of the evolution of the quantity of ctDNA will be studied from pre-treatment, during treatment and up to 24 months of post-treatment follow-up.

Time frame
At 1 month post-treatment

Other outcomes

Sponsors and contacts

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