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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ethyol (drug)

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Local and regional tumor control

Full Information

NCT ID

NCT00167908

First Posted

September 9, 2005

Last Updated

February 3, 2009

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00167908

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Washington University School of Medicine

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

27 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ethyol (drug)

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Local and regional tumor control

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wade Thorstad, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Head and Neck Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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