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

NCT ID: NCT01548846

Last Updated: 2015-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Head and Neck Cancer; Radiotherapy by Tomotherapy Exclusive; With or Without Concurrent Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Tomotherapy

Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT

Intervention Type: RADIATION

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

bernard GERY, MD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

Centre François BACLESSE

Caen, , France

Countries

France

Other Identifiers

TOQUAL

Identifier Type: -

Identifier Source: org_study_id