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NCT00158691 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00158691
Other study ID # GORTEC 2000-02
Secondary ID
Status Completed
Phase Phase 3
First received September 8, 2005
Last updated September 8, 2005
Start date March 2001

Study information
Verified date September 2005
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 296
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ethyol

Locations
Country Name City State
France Centre Régional de Lutte contre le Cancer de Nantes-Atlantique Nantes

Sponsors (2)
Lead Sponsor Collaborator
Groupe Oncologie Radiotherapie Tete et Cou Schering-Plough

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Late xerostomia rate
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