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NCT Number: NCT03519048

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gustave Roussy

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Low Dose Chest CTscan

Other

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

injected CT-scan

Other

the first performed 12 months after inclusion

whole body PET-CT

Other

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

Lugol upper gastrointestinal endoscopy

Procedure

the first performed 12 months after inclusion

Biopsy

Procedure

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

Primary outcomes

  1. Overall Survival

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

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

Acronym: SURVEILL'ORL

Important dates

Study start
2018
Primary completion
2031
Study completion
2031
First posted
May 8, 2018
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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