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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— SURVEILL'ORL  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519048
• Other study ID #: 2017-A01254-49
• Secondary ID: 2017/2553
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 17, 2018
• Est. completion date: January 2031

Study information

• Verified date: March 2024
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 197
• Est. completion date: January 2031
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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
• injected CT-scan
the first performed 12 months after inclusion
• 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
• Biopsy
In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Up to 5 years