Status:
COMPLETED
Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas
Lead Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Collaborating Sponsors:
Schering-Plough
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 evaluat...
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 o...
Eligibility Criteria
Inclusion
- 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
- Distant metastases
- Prophylactic use of pilocarpine
- Concomitant chemotherapy
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00158691
Start Date
March 1 2001
Last Update
September 12 2005
Active Locations (1)
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1
Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
Nantes, France, 44805