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

NCT03519048 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: 2017-A01254-492017/2553
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Up to 5 years

Study Arms (2)

Conventional follow-up

ACTIVE COMPARATOR

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; Other: Low Dose Chest CTscan; Procedure: Biopsy

Intensive follow-up strategy

EXPERIMENTAL

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; Other: whole body PET-CT; Procedure: Lugol upper gastrointestinal endoscopy; Procedure: Biopsy

Interventions

Low Dose Chest CTscan OTHER

every year in patients with tobacco consumption history of \> 20 pack-year

Conventional follow-up

injected CT-scan OTHER

the first performed 12 months after inclusion

Intensive follow-up strategy

whole body PET-CT OTHER

annual whole body PET-CT (the first at 6 months after inclusion)

Intensive follow-up strategy

Biopsy PROCEDURE

In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.

Conventional follow-up; Intensive follow-up strategy

Nasofibroscopy PROCEDURE

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

Conventional follow-up

Lugol upper gastrointestinal endoscopy PROCEDURE

the first performed 12 months after inclusion

Intensive follow-up strategy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead
• National Cancer Institute, France: collaborator

Study Sites (1)

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stephane TEMAM, MD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: January 17, 2018
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)