Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTIX)

This study is currently recruiting participants.
Verified December 2013 by Center Eugene Marquis
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis
ClinicalTrials.gov Identifier:
NCT01874587
First received: April 25, 2013
Last updated: January 20, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Oropharynx Cancer
Radiation: adaptative radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Center Eugene Marquis:

Primary Outcome Measures:
  • Salivary flow measure [ Time Frame: 12 months after the end of radiotherapy ] [ Designated as safety issue: No ]
    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:
  • Xerostomia [ Time Frame: From before treatment to 24 months after the end of radiotherapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    measured by scintigraphy

  • Local control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    overall and disease free survival

  • Head and Neck functionality [ Time Frame: Before treatment to 24 months after the end of radiotherapy ] [ Designated as safety issue: No ]
    MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy


Estimated Enrollment: 174
Study Start Date: July 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01874587

Contacts
Contact: Renaud De Crevoisier, MD + 33 (0)2 99 25 30 31 r.de-crevoisier@rennes.unicancer.fr

Locations
France
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         
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    r.de-crevoisier@rennes.unicancer.fr   
Principal Investigator: Renaud De Crevoisier, MD         
CHU Tours Not yet recruiting
Tours, France, 37044
Principal Investigator: Gilles Calais, MD         
Sponsors and Collaborators
Center Eugene Marquis
Investigators
Principal Investigator: Renaud De Crevoisier, MD Centre Eugène Marquis - Rennes - France
  More Information

No publications provided

Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT01874587     History of Changes
Other Study ID Numbers: 2012-RdC-ORL-Th, 2012-A00426-37
Study First Received: April 25, 2013
Last Updated: January 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Center Eugene Marquis:
Adaptative radiotherapy
oropharynx carcinoma
xerostomia

Additional relevant MeSH terms:
Xerostomia
Carcinoma
Oropharyngeal Neoplasms
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

ClinicalTrials.gov processed this record on April 22, 2014