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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou
• Collaborator: Schering-Plough
• Treatments: Amifostine

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