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Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
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.
Official title: Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
35 Years - Any
Study Type
INTERVENTIONAL
Enrollment
197
Start Date
2018-01-17
Completion Date
2031-01
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Nasofibroscopy
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
Low Dose Chest CTscan
every year in patients with tobacco consumption history of \> 20 pack-year
injected CT-scan
the first performed 12 months after inclusion
whole body PET-CT
annual whole body PET-CT (the first at 6 months after inclusion)
Lugol upper gastrointestinal endoscopy
the first performed 12 months after inclusion
Biopsy
In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.
Locations (1)
Gustave Roussy
Villejuif, Val de Marne, France