Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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
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Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Procedure: Nasofibroscopy
* Other: Low Dose Chest CTscan
* Other: injected CT-scan
* Other: whole body PET-CT
* Procedure: Lugol upper gastrointestinal endoscopy
* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional follow-up<br>clinical examination with 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. Panendoscopy plus CT-scan are performed in case of clinical symptoms or abnormal clinical exam. | Procedure: Nasofibroscopy<br>* 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<br>Other: Low Dose Chest CTscan<br>* every year in patients with tobacco consumption history of > 20 pack-year<br>Procedure: Biopsy<br>* In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.<br>|
| Experimental: Intensive follow-up strategy<br>adding to the conventional follow-up strategy , an annual head&neck and thoracic injected CT-scan and Lugol upper gastrointestinal endoscopy (the first performed 12 months after inclusion), annual whole body PET-CT (the first at 6 months after inclusion). These 3 exams are performed every year during 3 years after inclusion (i.e. 3 CT-scan, 3 digestive endoscopies and 3 PET-CT per patient). Clinical follow up will be conducted as in the conventional follow up group and panendoscopy or bronchoscopy will be performed if needed. After 3 years, patients will be followed by conventional follow-up. | Other: injected CT-scan<br>* the first performed 12 months after inclusion<br>Other: whole body PET-CT<br>* annual whole body PET-CT (the first at 6 months after inclusion)<br>Procedure: Lugol upper gastrointestinal endoscopy<br>* the first performed 12 months after inclusion<br>Procedure: Biopsy<br>* In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Up to 5 years |