Trial 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.
NCT ID:
NCT06479070
Condition:
SCC - Squamous Cell Carcinoma
Upper Aero-digestive Tract (UADT) Neoplasm
Conditions: Official terms:
Carcinoma, Squamous Cell
Conditions: Keywords:
Squamous Cell Carcinoma
upper aero-digestive trac tumor
Ct DNA
Radiotherapy
Head and neck cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Cohorte, prospective and multicenter study.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood samples
Description:
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.
Arm group label:
Interventional arm
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.
Detailed description:
This is a prospective, multicenter cohort study carried out on a total of 188 patients
suffering from non-metastatic stage III and IV SCC-UADT (oral cavity, larynx, oropharynx,
hypopharynx, maxillary sinus), naïve to any treatment during a consultation or day
hospitalization during the radiotherapy consultation.
The objective of the 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. This objective will be achieved by quantitatively measuring the number of
copies of methylated ctDNA of genes of interest per mL of plasma; This measurement of
ctDNA will be evaluated by the rate of decrease in ctDNA between the centering scanner
sample and 1 month post-treatment. Two groups will be then considered: patients with a
reduction ≥ 85% and those with a reduction < 85%.
In addition, the interest of measuring the quantity of ctDNA at 1 month post-treatment as
a predictive factor of overall survival (OS) and specific survival (SS) at 24 months, the
kinetics of the evolution of the quantities of ctDNA during the treatment and during
follow-up up to 24 months and the evolution of ctDNA quantities during treatment and
follow-up as a predictive factor for PFS and OS at 24 months will also be evaluated
during this study. . The analyzes will be carried out in subgroups of populations
according to their p16 status (HPV viral protein) and according to the presence or
absence of concomitant treatment (Cisplatin or Cetuximab).
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Recruiting
Contact:
Last name:
TOSTI PT PRISCILLIA, PhD.
Phone:
0383598657
Email:
p.tosti@nancy.unicancer.fr
Contact backup:
Last name:
FAIVRE JCF JEAN-CHRISTOPHE, MD.
Facility:
Name:
CHU Besançon
Address:
City:
Besançon
Zip:
25030
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
CORROTTE CC CELINE
Phone:
03 70 63 20 65
Email:
ccorrotte@chu-besancon.fr
Contact backup:
Last name:
BOUSTANI JB JIHANE, MD.
Facility:
Name:
Centre Georges-François Leclerc
Address:
City:
Dijon
Zip:
21000
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
TIAGO ST Sandrine
Phone:
03 80 73 75 00
Email:
stiago@cgfl.fr
Contact backup:
Last name:
TRUC GT GILLES, MD.
Facility:
Name:
Intitut Jean Godinot
Address:
City:
Reims
Zip:
51100
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
MAUBERT ASM ANNE-SOPHIE
Phone:
03 26 50 41 84
Email:
annesophie.maubert@reims.unicancer.fr
Contact backup:
Last name:
BEDDOK AB Arnaud, MD.
Facility:
Name:
Institut de Cancérologie Strasbourg Europe
Address:
City:
Strasbourg
Zip:
67033
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
SARTORI VS VALERIE
Phone:
03 68 76 72 23
Email:
v.sartori@icans.eu
Contact backup:
Last name:
BRAHIMI YB Youssef, MD.
Start date:
September 30, 2024
Completion date:
September 30, 2029
Lead sponsor:
Agency:
Institut de Cancérologie de Lorraine
Agency class:
Other
Source:
Institut de Cancérologie de Lorraine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06479070
