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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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

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 (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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Late xerostomia rate

Principal Investigator

Etienne Bardet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Régional de Lutte contre le Cancer de Nantes-Atlantique

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GORTEC 2000-02

NCT ID:

NCT00158691

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck cancer
  • Radiotherapy
  • Xerostomia
  • Randomized trial
  • Carcinoma
  • Head and Neck Neoplasms
  • Xerostomia
  • Carcinoma, Squamous Cell

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