CompletedNot Applicable

Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTOME)

France132 participantsStarted 2013-07-05

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 cont…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cost utility analysis of standard radiotherapy (one pretherapeutic planification) compared to adaptative (weekly planification)

Timeframe: 2 years after end of radiotherapy treatment

Trial details

NCT IDNCT05025618

SponsorCenter Eugene Marquis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-10

View on ClinicalTrials.gov More Oropharynx Cancer trials