Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract (TOQUAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Francois Baclesse
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01548846
First received: March 6, 2012
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Radiotherapy by Tomotherapy Exclusive
With or Without Concurrent Chemotherapy
Radiation: Tomotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • the proportion of patients with xerostomia [ Time Frame: 12 months after completion of radiotherapy. ] [ Designated as safety issue: No ]
    Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy.


Secondary Outcome Measures:
  • Evaluation of acute and late xerostomia [ Time Frame: after 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluation of acute xerostomia

  • Measurement of salivary flow with and without stimulation [ Time Frame: at 3, 6 and 12 months after end of radiotherapy ] [ Designated as safety issue: No ]
    Measurement of salivary flow with and without stimulation

  • Evaluation of the incidence of acute side effects of radiotherapy [ Time Frame: Weekly during radiotherapy ] [ Designated as safety issue: No ]
    Evaluation of the incidence of acute and late side effects of radiotherapy

  • Evaluation of the incidence of late side effects of radiotherapy [ Time Frame: At 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluation of the incidence of late side effects of radiotherapy

  • Evaluation of quality of life and fatigue [ Time Frame: At 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluation of quality of life and fatigue

  • Evaluation of overall survival and progression-free survival [ Time Frame: at 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]
    Evaluation of overall survival and progression-free survival


Estimated Enrollment: 44
Study Start Date: May 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Tomotherapy
    Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient (e) old (e) over 18 years
  • Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
  • Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
  • Indication of head and neck radiotherapy bilateral
  • All of the TNM stage except metastatic
  • Patient has signed informed consent for participation in the study
  • Mastery of the French language

Exclusion Criteria:

  • History of head and neck radiotherapy
  • Indication of head and neck radiotherapy unilateral
  • Personal history of malignant tumors uncontrolled over the past 5 years
  • History of oral sicca syndrome
  • Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
  • Concomitant treatment with amifostine
  • Concomitant treatment with cetuximab
  • Primary tumor of the salivary glands
  • Head and neck hyperfractionated radiotherapy and / or accelerated
  • Head and neck radiotherapy hypofractionated
  • Metastatic disease
  • Patient deprived of liberty, under guardianship
  • Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
  • Refusal of the patient.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548846

Contacts
Contact: Bernard GERY, MD b.gery@baclesse.fr
Contact: Victor PERNIN v.pernin@baclesse.fr

Locations
France
Centre François BACLESSE Recruiting
Caen, France, 14076
Contact: Bernard GERY, MD       b.gery@baclesse.fr   
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: bernard GERY, MD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01548846     History of Changes
Other Study ID Numbers: TOQUAL
Study First Received: March 6, 2012
Last Updated: March 25, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Francois Baclesse:
tomotherapy
xerostomy
head and neck squamous cell carcinoma

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Mouth Diseases
Neoplasms
Neoplasms by Site
Salivary Gland Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014