Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME) (ARTOME)

August 30, 2021 updated by: Center Eugene Marquis

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.

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated for oropharynx cancer in specialized hospitals

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years after end of radiotherapy treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Renaud De Crevoisier, Professor, Centre Eugene Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2013

Primary Completion (Actual)

December 10, 2019

Study Completion (Actual)

December 8, 2020

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-7-10-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oropharynx Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe