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CompletedNCT05025618ARTOMEUpdated Sep 5, 2021

Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)

An observational study in Oropharynx Cancer, sponsored by Center Eugene Marquis. Completed at 11 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by Center Eugene Marquis · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
132
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Oropharynx Cancer

Keywords

  • adaptative radiotherapy
  • xerostomia
  • medico-economic assessment
03

In context

Oropharyngeal Neoplasms

373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.

This study's enrollment of 132 is above the median of 111 across 66 observational studies indexed under Oropharyngeal Neoplasms.

Browse Oropharyngeal Neoplasms studies →

Lead sponsor

Center Eugene Marquis is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients treated for oropharynx cancer in specialized hospitals

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
132 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years after end of radiotherapy treatment

07

Study locations

11 sites
  • Clinique Claude Bernard
    Albi, France
  • Clinique Pasteur Lanroze
    Brest, France
  • CRLCC Baclesse
    Caen, 14076, France
  • CRLCC Oscar Lambret
    Lille, 59020, France
  • Centre Léon Bérard
    Lyon, France
  • CRLCC Antoine Lacassagne
    Nice, 06189, France
  • CHU de la Milétrie
    Poitiers, 86000, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • CRLCC Henri Becquerel
    Rouen, France
  • Centre Paul Strauss
    Strasbourg, France
  • CHU Tours - Hôpital Bretonneau
    Tours, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05025618
Lead sponsor
Center Eugene Marquis
Responsible party
Sponsor
First posted
Aug 27, 2021
Start date
Jul 5, 2013
Primary completion
Dec 10, 2019
Completion
Dec 8, 2020
Last update
Sep 5, 2021

Study contacts

Renaud De Crevoisier, Professor
principal investigator · Centre Eugène Marquis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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