MedTrace Logo

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

NCT03519048 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2026-03-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Stephane TEMAM, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519048 on ClinicalTrials.gov