MedDataX Logo

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

NCT ID: NCT00158691

Last Updated: 2005-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Head and Neck cancer Radiotherapy Xerostomia Randomized trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ethyol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Schering-Plough

INDUSTRY

Sponsor Role collaborator

Groupe Oncologie Radiotherapie Tete et Cou

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Etienne Bardet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Régional de Lutte contre le Cancer de Nantes-Atlantique

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Régional de Lutte contre le Cancer de Nantes-Atlantique

Nantes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1053/sonc.2002.37348.

Reference Type BACKGROUND
PMID: 12577246 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GORTEC 2000-02

Identifier Type: -

Identifier Source: org_study_id