Head and Neck CancerPhase 2NCT00167908
Study of Amifostine and IMRT for Protecting Salivary Glands in Head and Neck Cancer
A Phase 2 study testing Ethyol (drug) in people with Head and Neck Cancer, run by Washington University School of Medicine.
Trial summary
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Ethyol (drug)
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Metastatic disease.
- Patient using Salagen or concurrent chemotherapy.
- Previous XRT for head and neck tumors.
- Active untreated infection.
About this study
Official title: Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.
- Conditions
- Head and Neck Cancer
- Being tested
- Ethyol (drug)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyol (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary function at 6 months and yearly compared to pre-treatment salivary function
Secondary outcomes (1)
Local and regional tumor control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2001
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Wade Thorstad, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167908
- Sponsor's protocol ID
- ETH018-01D
- Other IDs
- HSC 00-0885
- Status last verified
- Feb 2009
- First submitted
- 9 Sep 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Test Whether Amifostine Can Further Protect Salivary Function in Head and Neck Cancer Patients Treated With IMRT
- ClinicalTrials.gov ID
- NCT00167908
- Acronym / sponsor ID
- ETH018-01D
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- May 2007 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Amifostine provides additional protection of salivary gland function over that achieved with IMRT alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- Metastatic disease.
- Patient using Salagen or concurrent chemotherapy.
- Previous XRT for head and neck tumors.
- Active untreated infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethyol (drug) | Drug | – |
Primary outcome
Salivary function at 6 months and yearly compared to pre-treatment salivary function
1 secondary outcome
Local and regional tumor control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wade Thorstad, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ethyol (drug) in people with Head and Neck Cancer, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary function at 6 months and yearly compared to pre-treatment salivary function. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.