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

This study has been completed.

First Received on September 8, 2005. No Changes Posted

Sponsor:	Groupe Oncologie Radiotherapie Tete et Cou
Collaborator:	Schering-Plough
Information provided by:	Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:	NCT00158691

Purpose

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	Intervention	Phase
Head and Neck Cancer	Drug: Ethyol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dry Mouth Head and Neck Cancer

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:

Late xerostomia rate

Estimated Enrollment:	296
Study Start Date:	March 2001

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158691

Locations

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

Principal Investigator:

Etienne Bardet, MD

Centre Régional de Lutte contre le Cancer de Nantes-Atlantique

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

ClinicalTrials.gov Identifier:	NCT00158691 History of Changes
Other Study ID Numbers:	GORTEC 2000-02
Study First Received:	September 8, 2005
Last Updated:	September 8, 2005
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:

Head and Neck cancer
Radiotherapy
Xerostomia
Randomized trial

Additional relevant MeSH terms:

Carcinoma
Head and Neck Neoplasms
Xerostomia
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Salivary Gland Diseases

Mouth Diseases
Stomatognathic Diseases
Neoplasms, Squamous Cell
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012