Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract (TOQUAL)
This study is currently recruiting participants.
Verified March 2012 by Centre Francois Baclesse
Sponsor:
Centre Francois Baclesse
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01548846
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Radiotherapy by Tomotherapy Exclusive With or Without Concurrent Chemotherapy |
Radiation: Tomotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract |
Resource links provided by NLM:
Further study details as provided by Centre Francois Baclesse:
Primary Outcome Measures:
- the proportion of patients with xerostomia [ Time Frame: 12 months after completion of radiotherapy. ] [ Designated as safety issue: No ]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:
- Evaluation of acute and late xerostomia [ Time Frame: after 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]Evaluation of acute xerostomia
- Measurement of salivary flow with and without stimulation [ Time Frame: at 3, 6 and 12 months after end of radiotherapy ] [ Designated as safety issue: No ]Measurement of salivary flow with and without stimulation
- Evaluation of the incidence of acute side effects of radiotherapy [ Time Frame: Weekly during radiotherapy ] [ Designated as safety issue: No ]Evaluation of the incidence of acute and late side effects of radiotherapy
- Evaluation of the incidence of late side effects of radiotherapy [ Time Frame: At 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]Evaluation of the incidence of late side effects of radiotherapy
- Evaluation of quality of life and fatigue [ Time Frame: At 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]Evaluation of quality of life and fatigue
- Evaluation of overall survival and progression-free survival [ Time Frame: at 3, 6 and 12 months after radiotherapy ] [ Designated as safety issue: No ]Evaluation of overall survival and progression-free survival
| Estimated Enrollment: | 44 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Radiation: Tomotherapy
Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Neoadjuvant Chemotherapy
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548846
Contacts
| Contact: Bernard GERY, MD | b.gery@baclesse.fr | |
| Contact: Victor PERNIN | v.pernin@baclesse.fr |
Locations
| France | |
| Centre François BACLESSE | Recruiting |
| Caen, France, 14076 | |
| Contact: Bernard GERY, MD b.gery@baclesse.fr | |
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
| Principal Investigator: | bernard GERY, MD | Centre François Baclesse |
More Information
No publications provided
| Responsible Party: | Centre Francois Baclesse |
| ClinicalTrials.gov Identifier: | NCT01548846 History of Changes |
| Other Study ID Numbers: | TOQUAL |
| Study First Received: | March 6, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Francois Baclesse:
|
tomotherapy xerostomy head and neck squamous cell carcinoma |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Xerostomia Neoplasms by Site Neoplasms |
Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013