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

• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou (Other)
• Overall Status: Completed
• CT.gov ID: NCT00158691
• Collaborator: Schering-Plough (Industry)
• Enrollment: 296
• Location: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Ethyol	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2001

Outcome Measures

Primary Outcome Measures

1. Late xerostomia rate []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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
• Other Study ID Numbers: GORTEC 2000-02
• First Posted: Sep 12, 2005
• Last Update Posted: Sep 12, 2005
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Head and Neck cancer; Radiotherapy; Xerostomia; Randomized trial
• Additional relevant MeSH terms: Head and Neck Neoplasms; Xerostomia; Amifostine

Study Results

No Results Posted as of Sep 12, 2005