NCT03519048Active, not recruitingPhase 3
Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 197 (actual)
- First submitted
- 26 Apr 2018
- Start date
- 17 Jan 2018
- Primary completion date
- Jan 2031
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Diseases
- Head and neck cancer
- NCT number
- NCT03519048
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 197
- From 17 Jan 2018 to the primary completion date, Jan 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignancies within 5 years prior to randomization that needs followup by PET-scan or chest CT or head and neck CT/MRI
Other illness
- 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.
- Any disease that needs follow-up by regular upper digestive endoscopy
Other
- Pregnant or breastfeeding women
- Impossibility to perform the planned exams of the intensive strategy
- Nasopharyngeal carcinoma
Who the study is looking for
- 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
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.