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OpenTrials
Completed

NCT Number: NCT00167908

Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer

The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed squamous cell cancer of the head and neck
  • Eligible sites: oral cavity, oropharynx, hypopharynx, larynx.
  • Patients requiring postoperative IMRT.
  • KPS > 70%.
  • Patient has signed specific protocol consent prior to registration.
  • Calcium test within normal limits.
  • No previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years.
  • Labs completed with 30 days of registration (CBC & platelet, Ca++, Alk phos, SGOT, Bili, albumin) CXR and CT simulation.
  • Liver CT if alk phos, SGOT, or bili elevated.
  • Bone scan if elevated alk phos

Exclusion criteria

  • Metastatic disease.
  • Patient using Salagen or concurrent chemotherapy.
  • Previous XRT for head and neck tumors.
  • Active untreated infection.

Treatment and study plan

Ethyol (drug)

Drug

Primary outcomes

  1. Salivary function at 6 months and yearly compared to pre-treatment salivary function

Secondary outcomes

  1. Local and regional tumor control

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT

Important dates

Study start
2001
Study completion
2007
First posted
Sep 14, 2005
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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