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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status

Active

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Nasofibroscopy

Low Dose Chest CTscan

injected CT-scan

whole body PET-CT

Lugol upper gastrointestinal endoscopy

Biopsy

About this trial

This is an interventional other trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional follow-up

Intensive follow-up strategy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Full Information

NCT ID

NCT03519048

First Posted

April 26, 2018

Last Updated

January 19, 2023

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

National Cancer Institute, France

1. Study Identification

Unique Protocol Identification Number

NCT03519048

Brief Title

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

Acronym

SURVEILL'ORL

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 17, 2018 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional follow-up

Arm Type

Active Comparator

Arm Description

Arm Title

Intensive follow-up strategy

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Nasofibroscopy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Low Dose Chest CTscan

Intervention Description

every year in patients with tobacco consumption history of > 20 pack-year

Intervention Type

Other

Intervention Name(s)

injected CT-scan

Intervention Description

the first performed 12 months after inclusion

Intervention Type

Other

Intervention Name(s)

whole body PET-CT

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Lugol upper gastrointestinal endoscopy

Intervention Description

the first performed 12 months after inclusion

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephane TEMAM, MD

Organizational Affiliation

Gustave Roussy, Cancer Campus, Grand Paris

Official's Role

Study Chair

Facility Information:

Facility Name

Gustave Roussy

City

Villejuif

State/Province

Val De Marne

ZIP/Postal Code

94805

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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