NCT03519048

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	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
OTHER	Low Dose Chest CTscan	every year in patients with tobacco consumption history of \> 20 pack-year
OTHER	injected CT-scan	the first performed 12 months after inclusion
OTHER	whole body PET-CT	annual whole body PET-CT (the first at 6 months after inclusion)
PROCEDURE	Lugol upper gastrointestinal endoscopy	the first performed 12 months after inclusion
PROCEDURE	Biopsy	In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.

Timeline

• Start date: 2018-01-17
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2018-05-08
• Last updated: 2026-03-30

Locations

1 site across 1 country: France