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

This study has been terminated.
(lack of recrutment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548846
First Posted: March 8, 2012
Last Update Posted: March 13, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Francois Baclesse
  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: Intervention Model: Single Group Assignment
Masking: None (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. ]
    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 ]
    Evaluation of acute xerostomia

  • Measurement of salivary flow with and without stimulation [ Time Frame: at 3, 6 and 12 months after end of radiotherapy ]
    Measurement of salivary flow with and without stimulation

  • Evaluation of the incidence of acute side effects of radiotherapy [ Time Frame: Weekly during radiotherapy ]
    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 ]
    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 ]
    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 ]
    Evaluation of overall survival and progression-free survival


Enrollment: 11
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Tomotherapy
    Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT
  Eligibility

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01548846


Locations
France
Centre François BACLESSE
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: bernard GERY, MD Centre François Baclesse
  More Information

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01548846     History of Changes
Other Study ID Numbers: TOQUAL
First Submitted: March 6, 2012
First Posted: March 8, 2012
Last Update Posted: March 13, 2015
Last Verified: March 2014

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

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