Malignant Neoplasm of Head and NeckTEmPoRALNCT02469922
Positron Emission Tomography (PET) During Radio-chemotherapy to Treat Otorhinolaryngological Cancer
A study testing Positron emission tomography and radiochemotherapy in people with Malignant Neoplasm of Head and Neck and Locally Advanced Malignant Neoplasm, run by Center Eugene Marquis at 5 sites in France.
Trial summary
Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasm of Head and Neck, Locally Advanced Malignant Neoplasm
- What is being tested?
- Positron emission tomography and radiochemotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2014to 29 Jan 2021
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years
- invasive epidermoid carcinoma of head and neck (excluding nasopharyngeal), confirmed by histology
- locally advanced disease (non-metastatic stages AJCC III-IV). AJCC = American Joint Committee on Cancer
- performance status ECOG ≤ 2. ECOG = Eastern Cooperative Oncology Group
- no history of irradiation of the head and neck
- start of radiotherapy within 8 weeks after the pretreatment PET Scan
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- no surgery other than biopsy
- pregnancy test: negative for women of childbearing potential
- reliable contraception for a childbearing couple, men and woman must have a reliable contraception during treatment
- signed informed consent form
- patient with national health insurance
Who cannot join
- prior radiotherapy or chemotherapy
- history of other cancer except: cutaneous non-melanoma tumor and cervix in situ carcinoma
- unstable conditions (cardiovascular, renal, pulmonary) or systemic (lupus erythematosus, scleroderma)
- pregnant patient or patient with breastfeeding
- patient unable to give his consent
- patient under administrative supervision
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- patient who participates to another clinical trial on experimental drug
- regular follow-up impossible for various reasons (familial, economical, social, ...)
- diabetes
- accelerated radiotherapy protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Brest
Brest
Centre jean Bernard - Rue Victor Hugo
Le Mans, 72015
Hôpital du Scorff
Lorient
Centre Eugene Marquis
Rennes, 35042
Centre d'Oncologie St Vincent - Boulevard de la Boutière
Saint-Grégoire, 35460
About this study
Official title: Prospective Study Assessing Predictive Value of 18 F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography During Radio-chemotherapy for Locally Advanced Epidermoid Carcinoma of Head and Neck
Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years
- Being tested
- Positron emission tomography, radiochemotherapy
- 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.
radiochemotherapyRadiation
Every patients will be treated with radiochemotherapy as a standard of care
| Study group | Role | What they receive |
|---|---|---|
| Positron emission tomography | Experimental | Two additional PET Scan will be performed at 2 and 4 weeks for the first 30 patients. Then for the other patients only one additional PET-Scan will be performed Receives: Device: Positron emission tomography; Radiation: radiochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional relapse
Measured: 2 years
Secondary outcomes (1)
Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)
Measured: pretreatment, 15 days, 29 days, 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startJun 2014
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Head and NeckStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Castelli Joël, Doctor, Principal investigator, Centre de Lutte Contre le Cancer Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469922
- Sponsor's protocol ID
- 2013-JC-ORLK-TEP
- Other IDs
- IDRCB : 2013-A01219-36
- Acronym
- TEmPoRAL
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2014
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Assessing Predictive Value of 18 F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography During Radio-chemotherapy for Locally Advanced Epidermoid Carcinoma of Head and Neck
- ClinicalTrials.gov ID
- NCT02469922
- Acronym / sponsor ID
- TEmPoRAL / 2013-JC-ORLK-TEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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.
Open multicentric study assessing predictive value of 18-FDG PET (SUV max) at 20 Gy during radio-chemotherapy, on the loco-regional control after 2 years
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positron emission tomography | Experimental | Device: Positron emission tomography, Radiation: radiochemotherapyTwo additional PET Scan will be performed at 2 and 4 weeks for the first 30 patients. Then for the other patients only one additional PET-Scan will be performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years and ≤ 75 years
- invasive epidermoid carcinoma of head and neck (excluding nasopharyngeal), confirmed by histology
- locally advanced disease (non-metastatic stages AJCC III-IV). AJCC = American Joint Committee on Cancer
- performance status ECOG ≤ 2. ECOG = Eastern Cooperative Oncology Group
- no history of irradiation of the head and neck
Key exclusion criteria (10 listed)
- prior radiotherapy or chemotherapy
- history of other cancer except: cutaneous non-melanoma tumor and cervix in situ carcinoma
- unstable conditions (cardiovascular, renal, pulmonary) or systemic (lupus erythematosus, scleroderma)
- pregnant patient or patient with breastfeeding
- patient unable to give his consent
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 |
|---|---|---|
| Positron emission tomography | Device | Positron emission tomography |
| radiochemotherapyEvery patients will be treated with radiochemotherapy as a standard of care | Radiation | Positron emission tomography |
Primary outcome
Locoregional relapse
Time frame: 2 years
1 secondary outcome
Comparison of TEP scan values (Standardized Update Value max, Metabolic Tumor Volume)
Time frame: pretreatment, 15 days, 29 days, 3 months post treatment
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 27 Jul 2021.
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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.
Castelli Joël, Doctor principal investigator
Centre de Lutte Contre le Cancer Centre Eugène Marquis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron emission tomography and radiochemotherapy in people with Malignant Neoplasm of Head and Neck and Locally Advanced Malignant Neoplasm, run by Center Eugene Marquis at 5 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 11 inclusion and 10 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Locoregional relapse (time frame: 2 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 27 Jul 2021.