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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Wade Thorstad, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

ETH018-01D

NCT ID:

NCT00167908

Start Date:

October 2001

Completion Date:

May 2007

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck Neoplasms

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