Oropharynx CancerARTOMENCT05025618
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)
An observational study of Oropharynx Cancer, run by Center Eugene Marquis at 11 sites in France.
Trial summary
Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oropharynx Cancer
- How many people
- 132 participants
- Where
- 11 sitesFrance
- Study dates
- 5 Jul 2013to 8 Dec 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated for oropharynx cancer in specialized hospitals
Who may be able to join
- Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
- Age ≥ 18 years and ≤ 75 years
- Performance status (WHO ≤ 2)
- Renal, hepatic and cardiovascular functions allowing systemic treatment administration
- Adapted stomatologic care
- Signed informed consent form
- Membership or beneficiary of a national insurance scheme
Who cannot join
- Both parotids totally included in the target volume
- Stages T1 or T2 with positive node disease N1
- Neoadjuvant chemotherapy
- Exereses of primitive tumor and/or nodes
- History of other cancer within 5 years (except for basocellular epithelioma and cervical)
- Previous neck radiotherapy
Show all 14Show fewer
- Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy
- Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia) incompatible with study participation
- Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
- Patient already recruited in another biomedical research ( non interventional study is authorized)
- Pregnant or breast feeding patients
- Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
- Patient is deemed incapable of giving informed consent
- Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Clinique Claude Bernard
Albi
Clinique Pasteur Lanroze
Brest
CRLCC Baclesse
Caen, 14076
CRLCC Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon
CRLCC Antoine Lacassagne
Nice, 06189
CHU de la Milétrie
Poitiers, 86000
Centre Eugene Marquis
Rennes, 35042
CRLCC Henri Becquerel
Rouen
Centre Paul Strauss
Strasbourg
CHU Tours - Hôpital Bretonneau
Tours
About this study
Official title: Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia
Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.
Adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.
Read more
ARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.
ARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.
- Conditions
- Oropharynx Cancer
- Keywords
- adaptative radiotherapy, xerostomia, medico-economic assessment
- Medical subject headings
- Oropharyngeal Neoplasms, Xerostomia
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification)
The cost utility analysis is expressed in cost per one year life gained
Measured: 2 years after end of radiotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start5 Jul 2013
- Primary completion10 Dec 2019
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud De Crevoisier, Professor, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025618
- Sponsor's protocol ID
- 2015-7-10-002
- Acronym
- ARTOME
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia
- ClinicalTrials.gov ID
- NCT05025618
- Acronym / sponsor ID
- ARTOME / 2015-7-10-002
- Conditions
- Oropharynx Cancer
- Keywords
- adaptative radiotherapy, xerostomia, medico-economic assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 5 Jul 2013 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 27 Aug 2021 (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.
Standard treatment for oropharynx cancer is radiotherapy by intensity modulation with only one planification before treatment. Adaptative radiotherapy integrates one or several planifications during treatment radiotherapy in order to take into account anatomic modifications that occurs.
Adaptative radiotherapy is very expensive, complex and is consuming human resources as well as equipment.
ARTIX study (NCT01874587) entitled "Phase III trial testing the benefit of intensity-modulated radiotherapy with weekly replanifications versus intensity modulated radiotherapy with only one planification in locally advanced oropharynx carcinoma for decreasing xerostomia" is completed and clinical data from this study are used to analyse if xerostomia is decreased when adaptative radiotherapy is used.
ARTOME study will assess cost-efficiency and cost utility between standard treatment (one pretherapeutic planification) and experimental treatment (weekly replanifications during treatment). Clinical data from ARTIX study will be used for ARTOME study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for oropharynx cancer in specialized hospitals
Key inclusion criteria (7 listed)
- Locally advanced non-metastatic carcinoma of the oropharynx limited to T3 and T4 (whatever the N) and N2-N3 (whatever the T)(AJCC stage III-IV)
- Age ≥ 18 years and ≤ 75 years
- Performance status (WHO ≤ 2)
- Renal, hepatic and cardiovascular functions allowing systemic treatment administration
- Adapted stomatologic care
Key exclusion criteria (14 listed)
- Both parotids totally included in the target volume
- Stages T1 or T2 with positive node disease N1
- Neoadjuvant chemotherapy
- Exereses of primitive tumor and/or nodes
- History of other cancer within 5 years (except for basocellular epithelioma and cervical)
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
Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification)
Time frame: 2 years after end of radiotherapy treatment
The cost utility analysis is expressed in cost per one year life gained
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 5 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Renaud De Crevoisier, Professor principal investigator
Centre Eugène Marquis
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharynx Cancer, run by Center Eugene Marquis at 11 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 7 inclusion and 14 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification) (time frame: 2 years after end of radiotherapy treatment). 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 5 Sep 2021.