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

Gustave Roussy

Status and phase: Active, not recruiting; Phase 3

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Other: injected CT-scan; Procedure: Biopsy; Other: Low Dose Chest CTscan; Procedure: Lugol upper gastrointestinal endoscopy; Other: whole body PET-CT; Procedure: Nasofibroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03519048

2017-A01254-49

2017/2553 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

Conventional follow-up

Active Comparator group

Description:

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.

Treatment:

Procedure: Nasofibroscopy

Other: Low Dose Chest CTscan

Procedure: Biopsy

Intensive follow-up strategy

Experimental group

Description:

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.

Treatment:

Procedure: Lugol upper gastrointestinal endoscopy

Other: whole body PET-CT

Procedure: Biopsy

Other: injected CT-scan