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

Groupe Oncologie Radiotherapie Tete et Cou

Status and phase

Completed

Phase 3

Conditions

Head and Neck Cancer

Treatments

Drug: Ethyol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00158691

GORTEC 2000-02

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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