Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)

Completed

• Conditions: Oropharynx Cancer

• Registration Number: NCT05025618
• Lead Sponsor: Center Eugene Marquis

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07-05
• Primary Completion: 2019-12-10
• Study Completion: 2020-12-08
• Status Verified: 2021-08
• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-27
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification)	2 years after end of radiotherapy treatment	The cost utility analysis is expressed in cost per one year life gained

Trial Locations

Locations (11)

Clinique Claude Bernard; 🇫🇷 Albi, France

CRLCC Antoine Lacassagne; 🇫🇷 Nice, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CHU de la Milétrie; 🇫🇷 Poitiers, France

CRLCC Henri Becquerel; 🇫🇷 Rouen, France

CHU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

Clinique Pasteur Lanroze; 🇫🇷 Brest, France

CRLCC Oscar Lambret; 🇫🇷 Lille, France

CRLCC Baclesse; 🇫🇷 Caen, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France