Does more frequent Check-Ups after head and neck cancer save lives?
NCT ID NCT03519048
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a more intensive follow-up schedule after treatment for head and neck cancer helps people live longer compared to a standard schedule. It involves 197 smokers or heavy drinkers over age 35 who are cancer-free 2-4 months after treatment. The goal is to find the best way to monitor for cancer return.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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197 people
The number who actually took part.
- Started
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Jan 2018
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Gustave Roussy
Villejuif, Val de Marne, 94805, France
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