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

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ClinicalTrials.gov Identifier: NCT00158691
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Ethyol Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 296 participants
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
Study Start Date : March 2001

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Late xerostomia rate

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Etienne Bardet, MD Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00158691    
Other Study ID Numbers: GORTEC 2000-02
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 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:
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Head and Neck Neoplasms
Xerostomia
Neoplasms
Neoplasms by Site
Salivary Gland Diseases
Mouth Diseases
 Stomatognathic Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs