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

Head and Neck Cancer Clinical Trial

— TOQUAL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01548846
• Other study ID #: TOQUAL
• Status: Terminated
• Phase: Phase 2
• First received: March 6, 2012
• Last updated: March 12, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiotherapy by Tomotherapy Exclusive
• With or Without Concurrent Chemotherapy
• Xerostomia

Intervention

Radiation:
• Tomotherapy
Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT

Locations

Country	Name	City	State
France	Centre François BACLESSE	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of patients with xerostomia	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.	12 months after completion of radiotherapy.	No
Secondary	Evaluation of acute and late xerostomia	Evaluation of acute xerostomia	after 3, 6 and 12 months after radiotherapy	No
Secondary	Measurement of salivary flow with and without stimulation	Measurement of salivary flow with and without stimulation	at 3, 6 and 12 months after end of radiotherapy	No
Secondary	Evaluation of the incidence of acute side effects of radiotherapy	Evaluation of the incidence of acute and late side effects of radiotherapy	Weekly during radiotherapy	No
Secondary	Evaluation of the incidence of late side effects of radiotherapy	Evaluation of the incidence of late side effects of radiotherapy	At 3, 6 and 12 months after radiotherapy	No
Secondary	Evaluation of quality of life and fatigue	Evaluation of quality of life and fatigue	At 3, 6 and 12 months after radiotherapy	No
Secondary	Evaluation of overall survival and progression-free survival	Evaluation of overall survival and progression-free survival	at 3, 6 and 12 months after radiotherapy	No