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

Phase 2

Terminated

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

• Registration Number: NCT01548846
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-08
• Study Start: 2012-05
• Status Verified: 2014-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
the proportion of patients with xerostomia	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

Name	Time	Method
Evaluation of acute and late xerostomia	after 3, 6 and 12 months after radiotherapy	Evaluation of acute xerostomia
Evaluation of quality of life and fatigue	At 3, 6 and 12 months after radiotherapy	Evaluation of quality of life and fatigue
Evaluation of the incidence of acute side effects of radiotherapy	Weekly during radiotherapy	Evaluation of the incidence of acute and late side effects of radiotherapy
Evaluation of overall survival and progression-free survival	at 3, 6 and 12 months after radiotherapy	Evaluation of overall survival and progression-free survival
Measurement of salivary flow with and without stimulation	at 3, 6 and 12 months after end of radiotherapy	Measurement of salivary flow with and without stimulation
Evaluation of the incidence of late side effects of radiotherapy	At 3, 6 and 12 months after radiotherapy	Evaluation of the incidence of late side effects of radiotherapy

Trial Locations

Locations (1)

Centre François BACLESSE; 🇫🇷 Caen, France