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Completed

NCT Number: NCT05025618

Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Claude Bernard, Albi, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia

Acronym: ARTOME

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Aug 27, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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