Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
Phase III randomized trial to compare the efficacy in terms of overall survival of two follow-up strategies (conventional versus intensive) among smokers and/or alcohol drinkers patients, older than 35 year, in complete remission 2-4 months after treatment of head and neck squamous cell carcinoma Patients will be randomized after the post-treatment check-up (clinical examination and reference imaging including PET-CT for patients ≥ N2) performed 2 to 4 months after the end of treatment. The randomization ratio is 1:1.
Interventions
PROCEDURENasofibroscopy
every 1-3 months first year post-treatment, every 2-4 months second year, every 4-6 months third year (mean of around 13 visits) and every 6 months thereafter
OTHERLow Dose Chest CTscan
every year in patients with tobacco consumption history of \> 20 pack-year
OTHERinjected CT-scan
the first performed 12 months after inclusion
OTHERwhole body PET-CT
annual whole body PET-CT (the first at 6 months after inclusion)
PROCEDURELugol upper gastrointestinal endoscopy
the first performed 12 months after inclusion
PROCEDUREBiopsy
In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females aged superior to 35 years * Current or previous smokers (smoked more than 10 packs year) or alcohol drinkers (current or previous, more than 140 g alcohol per week) or both * Histologically proven invasive HNSCC stage 0 to IVa, excluding T4b and nasopharynx. Patients with in situ carcinoma are eligible. * Treated with curative intent * Free of cancer at the post-treatment clinical and radiological examination (negative PET-CT for N≥2) at least 2 months after the end of the last treatment and no later than 4 months after. If there is a strong doubt of lack of complete remission (for example if more exams or longer follow-up are needed to affirm or deny complete remission), the patient is not eligible for the trial. * Remark: Patients with several head and neck squamous cell carcinoma (concomitant or successive), all treated with curative intent and all in complete remission, are eligible. * Agree to have a long term follow-up * Signed informed consent * Patient affiliated to a social security system or beneficiary of the same
Exclusion criteria
* Pregnant or breastfeeding women * Severe psychiatric condition that may inhibit protocol participation and in the judgment of the investigator would make the patient inappropriate for entry into this study. * Impossibility to perform the planned exams of the intensive strategy * Nasopharyngeal carcinoma * Other malignancies within 5 years prior to randomization that needs followup by PET-scan or chest CT or head and neck CT/MRI * Any disease that needs follow-up by regular upper digestive endoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Up to 5 years |
Countries
France
Contacts
STUDY_CHAIRStephane TEMAM, MD
Gustave Roussy, Cancer Campus, Grand Paris
Outcome results
None listed