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Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma (ARTIX)

Primary Purpose

Oropharynx Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
adaptative radiotherapy
Sponsored by
Center Eugene Marquis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oropharynx Cancer focused on measuring Adaptative radiotherapy, oropharynx carcinoma, xerostomia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique Claude Bernard
  • Clinique Pasteur - Saint Esprit
  • CRLCC Baclesse
  • CRLCC Oscar Lambret
  • Centre Léon Bérard
  • CRLCC Antoine Lacassagne
  • CHU de la Milétrie
  • Centre Eugene Marquis
  • CRLCC Henri Becquerel
  • Centre Paul Strauss
  • CHU Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard radiotherapy

adaptative radiotherapy

Arm Description

single pre-treatment planning before radiotherapy

adaptive Radiotherapy based on a weekly replanning

Outcomes

Primary Outcome Measures

Salivary flow measure
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
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
measured by scintigraphy
Local control
analysed according stages T and N, HPV status
Early and late toxicities
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
overall and disease free survival
Head and Neck functionality
MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy

Full Information

First Posted
April 25, 2013
Last Updated
July 26, 2021
Sponsor
Center Eugene Marquis
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1. Study Identification

Unique Protocol Identification Number
NCT01874587
Brief Title
Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma
Acronym
ARTIX
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Cancer
Keywords
Adaptative radiotherapy, oropharynx carcinoma, xerostomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard radiotherapy
Arm Type
No Intervention
Arm Description
single pre-treatment planning before radiotherapy
Arm Title
adaptative radiotherapy
Arm Type
Experimental
Arm Description
adaptive Radiotherapy based on a weekly replanning
Intervention Type
Radiation
Intervention Name(s)
adaptative radiotherapy
Intervention Description
weekly replanning
Primary Outcome Measure Information:
Title
Salivary flow measure
Description
The salivary flow is measured after stimulation with Parafilm at the time of inclusion and then 12 months after the end of radiotherapy.
Time Frame
12 months after the end of radiotherapy
Secondary Outcome Measure Information:
Title
Xerostomia
Description
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
Time Frame
From before treatment to 24 months after the end of radiotherapy
Title
Salivary flow
Description
measured by scintigraphy
Time Frame
Before treatment and 12 months after the end of radiotherapy
Title
Local control
Description
analysed according stages T and N, HPV status
Time Frame
2 years
Title
Early and late toxicities
Description
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
Time Frame
From beginning of the radiotherapy up to 2 years after the end of radiotherapy
Title
Survival
Description
overall and disease free survival
Time Frame
2 years
Title
Head and Neck functionality
Description
MDASI-HN questionnaire before treatment, 3, 6, 12, 18 and 24 months after the end of radiotherapy
Time Frame
Before treatment to 24 months after the end of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud De Crevoisier, MD
Organizational Affiliation
Centre Eugène Marquis - Rennes - France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Claude Bernard
City
Albi
Country
France
Facility Name
Clinique Pasteur - Saint Esprit
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CRLCC Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CRLCC Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
CRLCC Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHU de la Milétrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
CRLCC Henri Becquerel
City
Rouen
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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Adaptative Radiotherapy to Decrease Xerostomia in Oropharynx Carcinoma

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