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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01548846
Other study ID # TOQUAL
Secondary ID
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


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
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