Cancer of Head and NeckRENOVATENCT03841175
Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers
An observational study of Cancer of Head and Neck, run by University Hospital, Brest at 1 site in France.
Trial summary
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- How many people
- 477 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2018to 1 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients referred for a pre-treatment FDG PET/CT of biopsy proven HSNCC
Who may be able to join
- biopsy proven HSNCC
- written consent
Who cannot join
- previous head and neck malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. The prognosis is strongly dependent on initial staging. The 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. Hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients.
The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract.
Read more
Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may alter the clinical management.
Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease.
Restaging impact on prognosis and clinical management remains poorly understood.
Therefore, the objective of this study is to assess the impact of the additional information provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis and clinical management, whatever the CWU stage.
- Conditions
- Cancer of Head and Neck
- Keywords
- Squamous cell carcinoma, FDG PET/CT, Initial staging, Clinical management, Prognosis
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT
Overall survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 May 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841175
- Sponsor's protocol ID
- RENOVATE ( 29BRC18.0012)
- Acronym
- RENOVATE
- Status last verified
- Apr 2018
- First submitted
- 13 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forecasts Impact of the Pre-therapeutic TEP-TDM in the 18-FDG Restaging of Upper Aero-digestive Tract Cancers
- ClinicalTrials.gov ID
- NCT03841175
- Acronym / sponsor ID
- RENOVATE / RENOVATE ( 29BRC18.0012)
- Conditions
- Cancer of Head and Neck
- Keywords
- Squamous cell carcinoma, FDG PET/CT, Initial staging, Clinical management, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Head and neck (HN) cancer is the sixth most common malignancy worldwide, with around 800 000 new cases and 320 000 deaths in 2015. These malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concern squamous cell carcinomas (HNSCC) 90% of the time. Despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade. The prognosis is strongly dependent on initial staging. The 5-year relative survival rate is 80,3% for patients with localized disease whereas it decreases to 47.2% when regional lymph node metastasis is known, and to 32.5% when distant metastasis is known. Hence, precise cancer staging is essential as it allows clinicians to select the appropriate treatment strategies and predict the prognosis of the patients.
The conventional work-up (CWU) includes physical examination, endoscopy, computed tomography (CT) and/or magnetic resonance imaging (MRI) of the head and neck to evaluate the initial local and regional HNSCC staging. Thoracic CT is recommended because the thorax is the most frequent location of remote metastasis and synchronous second cancer outside of the upper aerodigestive tract.
Some authors demonstrated that 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) had a higher sensitivity and specificity for determining the extent of the disease and was able to detect occult second primaries. Moreover 18-FDG PET-CT allows whole body assessment. This is why the use of 18-FDG PET-CT has increased significantly over the last several years. Added to initial CWU, 18-FDG PET-CT may restage HNSCC and as a result may alter the clinical management.
Pre-therapeutic 18F-FDG PET/CT is recommended by guidelines to assess remote extension of locally advanced HNSCC and/or to look for synchronous cancer but is not systematically indicated, particularly for localized disease.
Restaging impact on prognosis and clinical management remains poorly understood.
Therefore, the objective of this study is to assess the impact of the additional information provided by 18F-FDG PET-CT on HNSCC initial staging and whether restaging modify prognosis and clinical management, whatever the CWU stage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred for a pre-treatment FDG PET/CT of biopsy proven HSNCC
Key inclusion criteria (2 listed)
- biopsy proven HSNCC
- written consent
Key exclusion criteria (1 listed)
- previous head and neck malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT
Time frame: 10 years
Overall survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Head and Neck, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic impact of initial restaging HNSCC with 18F-FDG PET-CT (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.