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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Radiotherapy by Tomotherapy Exclusive, With or Without Concurrent Chemotherapy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

the proportion of patients with xerostomia

Outcome 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.

Outcome Time Frame:

12 months after completion of radiotherapy.

Safety Issue:

No

Principal Investigator

bernard GERY, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TOQUAL

NCT ID:

NCT01548846

Start Date:

March 2012

Completion Date:

June 2014

Related Keywords:

  • Head and Neck Cancer
  • Radiotherapy by Tomotherapy Exclusive
  • With or Without Concurrent Chemotherapy
  • tomotherapy
  • xerostomy
  • head and neck squamous cell carcinoma
  • Head and Neck Neoplasms
  • Xerostomia

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