EsophagitisPhase 2NCT00081315
Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
A Phase 2 study testing Amifostine in people with Esophagitis and Pneumonitis, run by MedImmune LLC at 24 sites in United States.
Trial summary
The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
- What is being tested?
- Amifostine
- How many people
- 130 participants
- Where
- 24 sitesUnited States
- Study dates
- Nov 2003to Aug 2006
- 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
You may be eligible for this study if you are 18 years of age or older and:
- Have UnResectable Stage IIIA or IIIB Non Small Cell Lung Cancer
- Have never had prior chemotherapy with Paclitaxel or Carboplatin
- Have never had prior thoracic radiation therapy (XRT)
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
St. Agnes Health Care
Baltimore, Maryland, 21229
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817
Cooper University Hospital
Camden, New Jersey, 08103
Charleston Cancer Center
Charleston, South Carolina, 29406
The Center for Radiation Oncology
Danville, Virginia, 24541
Providence Everett Medical Center
Everett, Washington, 98201
Chesapeake Oncology-Hematology Associates
Glen Burnie, Maryland, 21061
Florida Wellcare Alliance
Inverness, Florida, 34452
University of Kentucky
Lexington, Kentucky, 40536-0293
Cedars Sanai
Los Angeles, California, 90048
Cancer Center of Upper Delaware Valley
Milford, Pennsylvania, 18337
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Florida Community Cancer Center
New Port Richey, Florida, 34652
Beth Israel Hospital
New York, New York, 10003
Montgomery Cancer Center
Norristown, Pennsylvania, 19401
Ormand Memorial Cancer Center
Ormand Beach, Florida, 32174
Valley Medical Center
Renton, Washington, 98055
Upstate NY Cancer R&E Foundation
Rochester, New York, 14623
Radiation Oncology Center
Sacramento, California, 95816
Sarasota Memorial Hospital
Sarasota, Florida, 34239
St. John's Medical Research
Springfield, Missouri, 65807
University Community Hospital-Center for Cancer Care
Tampa, Florida, 33613
The Center for Cancer Care
Torrington, Connecticut, 06790
New Hanover Radiation
Wilmington, North Carolina, 28401
About this study
Official title: Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol®) Versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
The primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.
- Conditions
- Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
- Being tested
- Amifostine
- Keywords
- - Non-Small cell lung cancer
- Medical subject headings
- Esophagitis, Pneumonia, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.
Secondary outcomes (1)
- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2004 (estimated)
- Study startNov 2003
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luz Hammershaimb, M.D., Principal investigator, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081315
- Sponsor's protocol ID
- MI-CP079
- Status last verified
- Aug 2007
- First submitted
- 7 Apr 2004
- Last updated
- 21 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-Blind, Multicenter Trial of Subcutaneous Amifostine (Ethyol®) Versus Placebo in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00081315
- Acronym / sponsor ID
- MI-CP079
- Conditions
- Esophagitis, Pneumonitis, Non-Small Cell Lung Carcinoma
- Keywords
- - Non-Small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Aug 2006 (actual)
- First posted
- 9 Apr 2004 (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 primary objective of this study is to assess the activity of subcutaneous (SC) amifostine on the incidence and severity of acute radiochemotherapy-induced esophagitis in patients with unresectable Stage IIIA or IIIB non-small cell lung cancer (NSCLC) receiving combined modality therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Amifostine | Drug | – |
Primary outcome
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.
1 secondary outcome
- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT.
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 21 Aug 2007.
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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.
Luz Hammershaimb, M.D. principal investigator
MedImmune LLC
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amifostine in people with Esophagitis and Pneumonitis, run by MedImmune LLC at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment.. 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 21 Aug 2007.