Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01874587
Recruitment Status : Recruiting
First Posted : June 11, 2013
Last Update Posted : November 22, 2017
Information provided by (Responsible Party):
Center Eugene Marquis

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 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
Study Start Date : July 2013
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT01874587

Contact: Renaud De Crevoisier, MD + 33 (0)2 99 25 30 31

Clinique Claude Bernard Recruiting
Albi, France
Contact: Pierre Auberdiac, MD         
Principal Investigator: Pierre Auberdiac, MD         
Clinique Pasteur - Saint Esprit Recruiting
Brest, France, 29200
Contact: Ali Hasbini, MD         
CRLCC Baclesse Not yet recruiting
Caen, France, 14076
Principal Investigator: Bernard Gery, MD         
CRLCC Oscar Lambret Recruiting
Lille, France, 59020
Principal Investigator: Bernard Coche-Dequeant, MD         
Centre Léon Bérard Recruiting
Lyon, France
Contact: Pascal Pommier, MD         
Principal Investigator: Pascal Pommier, MD         
CRLCC Antoine Lacassagne Recruiting
Nice, France, 06189
Principal Investigator: Karen Benezery, MD         
CHU de la Milétrie Recruiting
Poitiers, France, 86000
Principal Investigator: René-Jean Bensadoun, MD         
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Renaud De Crevoisier, MD    +33 (0)2 99 25 30 31   
Principal Investigator: Renaud De Crevoisier, MD         
CRLCC Henri Becquerel Recruiting
Rouen, France
Contact: Sébastien Thureau, MD         
Principal Investigator: Sébastien Thureau, MD         
Centre Paul Strauss Recruiting
Strasbourg, France
Contact: Sébastien Guihard         
Principal Investigator: Sébastien Guihard, MD         
CHU Tours Recruiting
Tours, France, 37044
Principal Investigator: Gilles Calais, MD         
Sponsors and Collaborators
Center Eugene Marquis
Principal Investigator: Renaud De Crevoisier, MD Centre Eugène Marquis - Rennes - France

Responsible Party: Center Eugene Marquis Identifier: NCT01874587     History of Changes
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: November 22, 2017
Last Verified: June 2016

Keywords provided by Center Eugene Marquis:
Adaptative radiotherapy
oropharynx carcinoma

Additional relevant MeSH terms:
Mouth Diseases
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Salivary Gland Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Otorhinolaryngologic Diseases