Clinical trial NCT01548846: Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
Official title: Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Cancer
Radiotherapy by Tomotherapy Exclusive
With or Without Concurrent Chemotherapy
Keywords: tomotherapy
xerostomy
head and neck squamous cell carcinoma
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


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.

Primary outcomes:
measure: the proportion of patients with xerostomia
timeFrame: 12 months after completion of radiotherapy.
Secondary outcomes:
measure: Evaluation of acute and late xerostomia
timeFrame: after 3, 6 and 12 months after radiotherapy
measure: Measurement of salivary flow with and without stimulation
timeFrame: at 3, 6 and 12 months after end of radiotherapy
measure: Evaluation of the incidence of acute side effects of radiotherapy
timeFrame: Weekly during radiotherapy
measure: Evaluation of the incidence of late side effects of radiotherapy
timeFrame: At 3, 6 and 12 months after radiotherapy
measure: Evaluation of quality of life and fatigue
timeFrame: At 3, 6 and 12 months after radiotherapy
measure: Evaluation of overall survival and progression-free survival
timeFrame: at 3, 6 and 12 months after radiotherapy
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François BACLESSE
Study officials:
affiliation: Centre François Baclesse
name: bernard GERY, MD
role: PRINCIPAL_INVESTIGATOR
References: