Clinical trial · Interventional
Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
NCT01548846CI-TRIAL-00017130TOQUALterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recrutment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Radiotherapy by Tomotherapy Exclusive | — | UNRESOLVED | — |
| With or Without Concurrent Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the proportion of patients with xerostomia
- timeFrame
- 12 months after completion of radiotherapy.
- description
- 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 outcomes (6)
- measure
- Evaluation of acute and late xerostomia
- timeFrame
- after 3, 6 and 12 months after radiotherapy
- description
- Evaluation of acute xerostomia
- measure
- Measurement of salivary flow with and without stimulation
- timeFrame
- at 3, 6 and 12 months after end of radiotherapy
- description
- Measurement of salivary flow with and without stimulation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.