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ACTIVE NOT RECRUITING
NCT03519048
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Gustave Roussy

Villejuif, Val de Marne, France