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Trial record 1 of 1 for:    artix | France
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Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTIX)

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ClinicalTrials.gov Identifier: NCT01874587
Recruitment Status : Active, not recruiting
First Posted : June 11, 2013
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

Study Description
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Brief Summary:
The Phase III study will include 174 patients with locally advanced oropharynx carcinoma, receiving all arc-IMRT (Intensity-Modulated Radiation Therapy) (70 Gy) with concomitant systemic therapy. Two arc-IMRT treatment arms will be compared: one "standard" arm based on the use of a single pre-treatment planning and one "experimental" arm (adaptive RT) based on a weekly replanning to spare the salivary glands. The main objective is to increase by 25% the salivary flow (Parafilm) 12 months after RT thanks to adaptive RT, while not decreasing local control. The secondary objectives are to increase the salivary flow (scintigraphy), reduce xerostomia, acute and late toxicities (Eisbruch questionnaire, MDAS-HN, v.4 CTCAE), while maintaining local control (stopping rule of the trial if difference>15%). 174 patients will be included in 6 French centers for 2 years and followed for 2 years. The HPV (Human Papillomavirus) status will be identified and the tumors frozen. A central IMRT QA (Quality Assurance) will be performed.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Radiation: adaptative radiotherapy Phase 3

Study Design
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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
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

Arms and Interventions
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Arm Intervention/treatment
No Intervention: standard radiotherapy
single pre-treatment planning before radiotherapy
Experimental: adaptative radiotherapy
adaptive Radiotherapy based on a weekly replanning
 Radiation: adaptative radiotherapy
weekly replanning


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Salivary flow [ Time Frame: Before treatment and 12 months after the end of radiotherapy ]
    measured by scintigraphy

  3. Local control [ Time Frame: 2 years ]
    analysed according stages T and N, HPV status

  4. 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

  5. Survival [ Time Frame: 2 years ]
    overall and disease free survival

  6. 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


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. 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)
  2. Age ≥ 18 years and ≤ 75 years
  3. Performance status (WHO ≤ 2)
  4. Renal, hepatic and cardiovascular functions allowing systemic treatment administration
  5. Adapted stomatologic care
  6. Signed informed consent form
  7. Membership or beneficiary of a national insurance scheme

Exclusion Criteria:

  1. Both parotids totally included in the target volume
  2. Stages T1 or T2 with positive node disease N1
  3. Neoadjuvant chemotherapy
  4. Exereses of primitive tumor and/or nodes
  5. History of other cancer within 5 years (except for basocellular epithelioma and cervical)
  6. Previous neck radiotherapy
  7. Platinum salts, 5FluoroUracile (5FU) agents or cetuximab chemotherapy considerations
  8. Unstable diseases (cardiovascular, renal, pulmonary, systemic lupus or sclerodermia)incompatible with study participation
  9. Patient participating in other therapeutic trial with experimental drug, 30 days before the inclusion.
  10. Patient already recruited in another biomedical research ( non interventional study is authorized)
  11. Pregnant or breast feeding patients
  12. Patient deprived of liberty, under tutorship, guardianship or placed under judicial protection
  13. Patient is deemed incapable of giving informed consent
  14. Patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Renaud De Crevoisier, MD Centre Eugène Marquis - Rennes - France
More Information
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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: January 27, 2020
Last Verified: January 2020
Keywords provided by Center Eugene Marquis:
Adaptative radiotherapy
oropharynx carcinoma
xerostomia
Additional relevant MeSH terms:
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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