Clinical trial NCT05025618: Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)
Official title: Medico-economic Assessment of Adaptative Radiotherapy to Decrease Xerostomia in Locally Advanced Oropharynx Xerostomia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharynx Cancer
Keywords: adaptative radiotherapy
xerostomia
medico-economic assessment
Lead sponsor: Center Eugene Marquis
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for oropharynx cancer in specialized hospitals

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification)
timeFrame: 2 years after end of radiotherapy treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Albi
country: France
facility: Clinique Claude Bernard
city: Brest
country: France
facility: Clinique Pasteur Lanroze
city: Caen
country: France
facility: CRLCC Baclesse
city: Lille
country: France
facility: CRLCC Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nice
country: France
facility: CRLCC Antoine Lacassagne
city: Poitiers
country: France
facility: CHU de la Milétrie
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: CRLCC Henri Becquerel
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
Study officials:
affiliation: Centre Eugène Marquis
name: Renaud De Crevoisier, Professor
role: PRINCIPAL_INVESTIGATOR
References: