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

G

Gustave Roussy

Status and phase

Active, not recruiting
Phase 3

Conditions

Head and Neck Squamous Cell Carcinoma

Treatments

Other: injected CT-scan
Procedure: Biopsy
Other: Low Dose Chest CTscan
Procedure: Lugol upper gastrointestinal endoscopy
Other: whole body PET-CT
Procedure: Nasofibroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03519048
2017-A01254-49
2017/2553 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

197 participants in 2 patient groups

Conventional follow-up
Active Comparator group
Description:
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.
Treatment:
Procedure: Nasofibroscopy
Other: Low Dose Chest CTscan
Procedure: Biopsy
Intensive follow-up strategy
Experimental group
Description:
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.
Treatment:
Procedure: Lugol upper gastrointestinal endoscopy
Other: whole body PET-CT
Procedure: Biopsy
Other: injected CT-scan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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