Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTIX)
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ClinicalTrials.gov Identifier: NCT01874587 |
Recruitment Status :
Completed
First Posted : June 11, 2013
Last Update Posted : July 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oropharynx Cancer | Radiation: adaptative radiotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 2013 |
Actual Primary Completion Date : | December 10, 2019 |
Actual Study Completion Date : | December 8, 2020 |
Arm | Intervention/treatment |
---|---|
No Intervention: standard radiotherapy
single pre-treatment planning before radiotherapy
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Experimental: adaptative radiotherapy
adaptive Radiotherapy based on a weekly replanning
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Radiation: adaptative radiotherapy
weekly replanning |
- Salivary flow measure [ Time Frame: 12 months after the end of radiotherapy ]The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.
- Xerostomia [ Time Frame: From before treatment to 24 months after the end of radiotherapy ]salivary flow measured after stimulation before treatment, 6months, 18 months and 24 months after the end of radiotherapy Eisbruch's questionnaire before treatment, at 3, 6, 12, 18 and 24 months after the end of radiotherapy
- Salivary flow [ Time Frame: Before treatment and 12 months after the end of radiotherapy ]measured by scintigraphy
- Local control [ Time Frame: 2 years ]analysed according stages T and N, HPV status
- Early and late toxicities [ Time Frame: From beginning of the radiotherapy up to 2 years after the end of radiotherapy ]early toxicity : weekly assessment during radiotherapy until 3 months after the end late toxicity : 6, 12, 18 and 24 months after the end of radiotherapy
- Survival [ Time Frame: 2 years ]overall and disease free survival
- Head and Neck functionality [ Time Frame: Before treatment to 24 months after the end of radiotherapy ]MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 considerations
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874587
France | |
Clinique Claude Bernard | |
Albi, France | |
Clinique Pasteur - Saint Esprit | |
Brest, France, 29200 | |
CRLCC Baclesse | |
Caen, France, 14076 | |
CRLCC Oscar Lambret | |
Lille, France, 59020 | |
Centre Léon Bérard | |
Lyon, France | |
CRLCC Antoine Lacassagne | |
Nice, France, 06189 | |
CHU de la Milétrie | |
Poitiers, France, 86000 | |
Centre Eugene Marquis | |
Rennes, France, 35042 | |
CRLCC Henri Becquerel | |
Rouen, France | |
Centre Paul Strauss | |
Strasbourg, France | |
CHU Tours | |
Tours, France, 37044 |
Principal Investigator: | Renaud De Crevoisier, MD | Centre Eugène Marquis - Rennes - France |
Responsible Party: | Center Eugene Marquis |
ClinicalTrials.gov Identifier: | NCT01874587 |
Other Study ID Numbers: |
2012-RdC-ORL-Th 2012-A00426-37 ( Registry Identifier: ANSM ) |
First Posted: | June 11, 2013 Key Record Dates |
Last Update Posted: | July 27, 2021 |
Last Verified: | July 2021 |
Adaptative radiotherapy oropharynx carcinoma xerostomia |
Carcinoma Oropharyngeal Neoplasms Xerostomia Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Salivary Gland Diseases Mouth Diseases |
Stomatognathic Diseases Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Pharyngeal Diseases Otorhinolaryngologic Diseases |