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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:
ClinicalTrials.gov Identifier:
NCT00158691
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
ClinicalTrials.gov Identifier: NCT00158691     History of Changes
Other Study ID Numbers: GORTEC 2000-02
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Xerostomia
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs


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