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Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00158691
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Prospective randomized study in order to compare intravenous versus subcutaneous administration of amifostine in patients receiving radiotherapy for head and neck cancer. Salivary flow will be evaluated during few years after the treatment by a clinical evaluation, the measure of the weight of saliva and a patient benefit questionnaire cotation.


Condition Intervention Phase
Head and Neck Cancer
 Drug: Ethyol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Comparing Intravenous Versus Subcutaneous Administration of Amifostine in Prevention of Xerostomia for Patients Receiving Radiotherapy for Head and Neck Carcinomas

Resource links provided by NLM:

Drug Information available for: Amifostine
U.S. FDA Resources

Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • Late xerostomia rate

Estimated Enrollment: 296
Study Start Date: March 2001
Detailed Description:

Prospective randomized study in order to compare intravenous (IV) versus subcutaneous (SC) administration of amifostine in patients receiving radiotherapy for head and neck cancer. IV administration of amifostine is 200 mg/m2/day in a short 3-min infusion 15 to 30 min before each fraction of radiotherapy. SC administration is 500mg/day in two slow 1.25 ml injections at two different sites 20 to 60 min before each radiotherapy fraction. Procedure requires antiemetic treatment and blood pressure monitoring in both arms.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • newly diagnosed squamous cell head and neck cancer
  • inclusion of at least 75% of both parotid glands within radiation fields that would receive at least 40 Gy
  • Neutrophils ≥ 2000 / mm, Platelets ≥ 100,000 / mm3, Creatinine < 130 / mmol.L-1, Transaminase ≤ 3 x upper limit

Exclusion Criteria:

  • Distant metastases
  • Prophylactic use of pilocarpine
  • Concomitant chemotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158691

Locations
France
Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
Nantes, France, 44805
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Schering-Plough
Investigators
Principal Investigator: Etienne Bardet, MD Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00158691     History of Changes
Other Study ID Numbers: GORTEC 2000-02
Study First Received: September 8, 2005
Last Updated: September 8, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
Head and Neck cancer
Radiotherapy
Xerostomia
Randomized trial

Additional relevant MeSH terms:
Carcinoma
Head and Neck Neoplasms
Xerostomia
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Salivary Gland Diseases
 Mouth Diseases
Stomatognathic Diseases
Neoplasms, Squamous Cell
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013