Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00081315
First received: April 7, 2004
Last updated: August 20, 2007
Last verified: August 2007
| Tracking Information | |||||
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| First Received Date ICMJE | April 7, 2004 | ||||
| Last Updated Date | August 20, 2007 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
- Acute radiochemotherapy-induced esophagitis will be assessed from the time of randomization through up to 3 months after completion of radiochemotherapy treatment. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00081315 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
- Acute radiochemotherapy-induced pneumonitis will be assessed until 6 months after the last dose of XRT. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Subcutaneous Amifostine (Ethyol®) in the Prevention of Radiochemotherapy-Induced Esophagitis and Pneumonitis in Patients With Unresectable Non-Small Cell Lung Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Amifostine | ||||
| Study Arm (s) | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 130 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | You may be eligible for this study if you are 18 years of age or older and:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00081315 | ||||
| Other Study ID Numbers ICMJE | MI-CP079 | ||||
| Has Data Monitoring Committee | |||||
| Responsible Party | |||||
| Study Sponsor ICMJE | MedImmune LLC | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | MedImmune LLC | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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