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

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT00158691
First received: September 8, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 8, 2005
September 8, 2005
March 2001
Not Provided
Late xerostomia rate
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Intravenous Versus Subcutaneous Amifostine in Prevention of Xerostomia After RT for Head and Neck Carcinomas
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
Drug: Ethyol
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
296
Not Provided
Not Provided

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
Both
18 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00158691
GORTEC 2000-02
Not Provided
Not Provided
Groupe Oncologie Radiotherapie Tete et Cou
Schering-Plough
Principal Investigator: Etienne Bardet, MD Centre Régional de Lutte contre le Cancer de Nantes-Atlantique
Groupe Oncologie Radiotherapie Tete et Cou
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP