NCT05025618

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2013

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

6.4 years

First QC Date

August 24, 2021

Last Update Submit

August 30, 2021

Conditions

Oropharynx Cancer

Keywords

adaptative radiotherapyxerostomiamedico-economic assessment

Outcome Measures

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

    2 years after end of radiotherapy treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for oropharynx cancer in specialized hospitals

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clinique Claude Bernard

Albi, France

Location

Clinique Pasteur Lanroze

Brest, France

Location

CRLCC Baclesse

Caen, 14076, France

Location

CRLCC Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, France

Location

CRLCC Antoine Lacassagne

Nice, 06189, France

Location

CHU de la Milétrie

Poitiers, 86000, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

CRLCC Henri Becquerel

Rouen, France

Location

Centre Paul Strauss

Strasbourg, France

Location

CHU Tours - Hôpital Bretonneau

Tours, France

Location

MeSH Terms

Conditions

Oropharyngeal NeoplasmsXerostomia

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesSalivary Gland DiseasesMouth Diseases

Study Officials

  • Renaud De Crevoisier, Professor

    Centre Eugène Marquis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 27, 2021

Study Start

July 5, 2013

Primary Completion

December 10, 2019

Study Completion

December 8, 2020

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)