Head and Neck Cancer, Radiotherapy by Tomotherapy Exclusive, With or Without Concurrent Chemotherapy
Conditions
Keywords
tomotherapy, xerostomy, head and neck squamous cell carcinoma
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.
Interventions
RADIATIONTomotherapy
Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT
Sponsors
Centre Francois Baclesse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 acute side effects of radiotherapy | Weekly during radiotherapy | Evaluation of the incidence of acute and late side effects of radiotherapy |
| 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 overall survival and progression-free survival | at 3, 6 and 12 months after radiotherapy | Evaluation of overall survival and progression-free survival |
| 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 |
Countries
France
Outcome results
None listed