Radiotherapy, Conformal (IMRT)CONTOURNCT03265873
Contribution of the ENT (Ear, Nose, and Throat) Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers
An observational study of Radiotherapy, Conformal (IMRT) and Head and Neck Cancer, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
Trial summary
Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Conformal (IMRT), Head and Neck Cancer, Otolaryngology
- What is being tested?
- Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Nov 2017to 13 Oct 2023
- 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: Adult patients with head and neck cancer who require radiotherapy.
Who may be able to join
- Age ≥ 18 years;
- Cancer of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, rhinopharynx, salivary glands, facial sinuses, orbital cavity, ear);
- Cancer confirmed by histopathological analysis;
- Therapeutic protocol including radiotherapy.
Who cannot join
- Any history of radiotherapy of the head and neck
- Synchronous head and neck cancer.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital d'Instruction des Armées
Clamart, 92140
Fondation Ophtalmologique A. de Rothschild
Paris, 75019
About this study
Official title: Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers
Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.
- Conditions
- Radiotherapy, Conformal (IMRT), Head and Neck Cancer, Otolaryngology, Surgeons, Radiation Oncologists
- Being tested
- Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.Other
The contouring of the different target volumes will be first performed by the radiotherapists. During the Head and Neck Tumor Board, the volumes initially determined by the radiotherapists will be analyzed jointly by the radiotherapists and the patient's ENT surgeon to carry out, if necessary, modifications, taking into account clinical observations, intraoperative findings (if any) and endoscopy findings. Concordance parameters will be calculated in a second time with the determined volumes (in particular, index of concordance, coefficient of similarity).
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start28 Nov 2017
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy, Conformal (IMRT)Studies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Philippe Clément, MD, Principal investigator, Hôpital d'Instruction des armées Percy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265873
- Sponsor's protocol ID
- DBU_2017_13
- Acronym
- CONTOUR
- Status last verified
- Oct 2023
- First submitted
- 28 Aug 2017
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the ENT Surgeon's Clinical Evaluation to the Contouring of Target Volumes and Organs Eligible for Radiotherapy in Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT03265873
- Acronym / sponsor ID
- CONTOUR / DBU_2017_13
- Conditions
- Radiotherapy, Conformal (IMRT), Head and Neck Cancer, Otolaryngology, Surgeons, Radiation Oncologists
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 29 Aug 2017 (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.
Radiotherapy (RT), surgery and chemotherapy (CT) are treatments for head and neck cancers, used alone or in combination. Conformal RT with Intensity Modulation (IMRT) is currently the reference technique. IMRT requires a precise definition of the target volumes to be treated and the anatomical structures to be protected from irradiation. Most studies of head and neck cancers published in the literature demonstrate the variability in the contouring of the target volumes between radiotherapists. This may have an impact on dosimetry. To date, no studies have evaluated the impact of the ENT surgeon's evaluation in volumes contouring. The aim of this study is to compare the volumes determined by the radiotherapists alone and those determined jointly by the radiotherapists and the ENT surgeon.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with head and neck cancer who require radiotherapy.
Key inclusion criteria (4 listed)
- Age ≥ 18 years;
- Cancer of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, rhinopharynx, salivary glands, facial sinuses, orbital cavity, ear);
- Cancer confirmed by histopathological analysis;
- Therapeutic protocol including radiotherapy.
Key exclusion criteria (2 listed)
- Any history of radiotherapy of the head and neck
- Synchronous head and neck cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.The contouring of the different target volumes will be first performed by the radiotherapists. During the Head and Neck Tumor Board, the volumes initially determined by the radiotherapists will be analyzed jointly by the radiotherapists and the patient's ENT surgeon to carry out, if necessary, modifications, taking into account clinical observations, intraoperative findings (if any) and endoscopy findings. Concordance parameters will be calculated in a second time with the determined volumes (in particular, index of concordance, coefficient of similarity). | Other | – |
Primary outcome
Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon.
Time frame: Baseline
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 26 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Radiotherapy, Conformal (IMRT)
Recruiting
SGRT in Head and Neck Cancer Radiotherapy
Head and Neck Cancer, Radiotherapy, Conformal (IMRT)
Active, not recruiting
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
RecruitingObservational study
BRAVE-HEART: Breast Cancer Radiotherapy Using Active Breathing Coordinator to aVoid Exposure of HEART
Breast Cancer, Radiotherapy
RecruitingObservational study
Radiotherapy of Head and Neck Cancer With SIB
Quality of Life (QOL), Head and Neck Cancer
Active, not recruitingPhase 3
Hypofractionated, Dose Escalation Radiotherapy for High Risk Adenocarcinoma of the Prostate
Prostate Cancer
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.
Philippe Clément, MD principal investigator
Hôpital d'Instruction des armées Percy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy, Conformal (IMRT) and Head and Neck Cancer, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites 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 4 inclusion and 2 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of patients with head and neck cancer for whom a change in the CTV (Clinical Target Volume) was made following the advice of the ENT surgeon. (time frame: Baseline). 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 26 Oct 2023.