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

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ClinicalTrials.gov Identifier: NCT03519048
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Procedure: Nasofibroscopy Other: Low Dose Chest CTscan Other: injected CT-scan Other: whole body PET-CT Procedure: Lugol upper gastrointestinal endoscopy Procedure: Biopsy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Multicentric Comparative Study Between a Conventional and an Intensive Follow up Strategy After Treatment of a Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : January 17, 2018
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2031

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Procedure: 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

Other: Low Dose Chest CTscan
every year in patients with tobacco consumption history of > 20 pack-year

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

Experimental: 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.
Other: injected CT-scan
the first performed 12 months after inclusion

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

Procedure: Lugol upper gastrointestinal endoscopy
the first performed 12 months after inclusion

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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519048


Contacts
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Contact: Stephane TEMAM, MD 0142114726 ext +33 stephane.temam@gustaveroussy.fr
Contact: Anne AUPERIN, MD 0142115499 ext +33 anne.auperin@gustaveroussy.fr

Locations
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France
Gustave Roussy Recruiting
Villejuif, Val De Arne, France, 94805
Contact: Stephane TEMAM, MD    0142114726 ext +33    stephane.temam@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Investigators
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Study Chair: Stephane TEMAM, MD Gustave ROUSSY

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT03519048     History of Changes
Other Study ID Numbers: 2017-A01254-49
2017/2553 ( Other Identifier: CSET number )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site