Study of Amifostine and IMRT for Protecting Salivary Glan... | NCT00167908

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

NCT00167908

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Feb 4, 2009Estimated

Enrollment

Phase

Phase 2

Conditions

Head and Neck Cancer

Interventions

Ethyol (drug)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HSC 00-0885

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2009

Last Update Posted Date

Feb 4, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ethyol (drug)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivary function at 6 months and yearly compared to pre-treatment salivary function

Secondary Outcomes

Measure	Description	Time Frame
Local and regional tumor control

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wade Thorstad, M.D.	Washington University School of Medicine	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004999	Amifostine
D004364	Pharmaceutical Preparations

Ancestor Terms

ID	Term
D063086	Organothiophosphates
D010755	Organophosphates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided