Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)

Oropharynx Cancer Clinical Trial

— ARTOME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05025618
• Other study ID #: 2015-7-10-002
• Status: Completed
• Start date: July 5, 2013
• Est. completion date: December 8, 2020

Study information

• Verified date: August 2021
• Source: Center Eugene Marquis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 8, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Xerostomia

Locations

Country	Name	City	State
France	Clinique Claude Bernard	Albi
France	Clinique Pasteur Lanroze	Brest
France	CRLCC Baclesse	Caen
France	CRLCC Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	CRLCC Antoine Lacassagne	Nice
France	CHU de la Milétrie	Poitiers
France	Centre Eugene Marquis	Rennes
France	CRLCC Henri Becquerel	Rouen
France	Centre Paul Strauss	Strasbourg
France	CHU Tours - Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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