Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
NCT ID: NCT03519048
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
197 participants
INTERVENTIONAL
2018-01-17
2031-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Conventional follow-up
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.
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
Biopsy
In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.
Intensive follow-up strategy
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.
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)
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.
Interventions
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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
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Stephane TEMAM, MD
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Gustave Roussy
Villejuif, Val De Marne, France
Countries
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Other Identifiers
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2017/2553
Identifier Type: OTHER
Identifier Source: secondary_id
2017-A01254-49
Identifier Type: -
Identifier Source: org_study_id
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