Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas
Information source: Groupe Oncologie Radiotherapie Tete et Cou
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: Ethyol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Groupe Oncologie Radiotherapie Tete et Cou Official(s) and/or principal investigator(s):
Etienne Bardet, MD, Principal Investigator, Affiliation: Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
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.
Clinical Details
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 design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Late xerostomia rate
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Centre Régional de Lutte contre le Cancer de Nantes-Atlantique, Nantes 44805, France
Additional Information
Related publications: Bardet E, Martin L, Calais G, Tuchais C, Bourhis J, Rhein B, Feham N, Alphonsi M. Preliminary data of the GORTEC 2000-02 phase III trial comparing intravenous and subcutaneous administration of amifostine for head and neck tumors treated by external radiotherapy. Semin Oncol. 2002 Dec;29(6 Suppl 19):57-60.
Starting date:
March 2001
Last updated: September 8, 2005
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