Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
Open-Label Prospective Trial Evaluating the Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities
1 other identifier
interventional
20
1 country
1
Brief Summary
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a drug approved to reduce the short and long-term occurrence of dry mouth when patients receive radiation treatment for head and neck cancer. Some studies have shown that Amifostine reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is still being investigated in lung malignancies. Amifostine is found to be a protectant from radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus, kidney and testes. Patients that receive radiation treatments for lung cancer may experience side effects involving the esophagus. It is hoped that patients will benefit from the protection of their esophagus and avoid delays in radiation treatment due to side effects of the radiation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable head-and-neck-cancer
Started Jun 2003
Shorter than P25 for not_applicable head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 12, 2005
CompletedFirst Posted
Study publicly available on registry
August 15, 2005
CompletedSeptember 27, 2005
August 1, 2005
August 12, 2005
September 26, 2005
Conditions
Outcome Measures
Primary Outcomes (2)
Primary endpoint: To evaluate how amifostine is given subcutaneously at each institution
To determine treatment related toxicities and safety of subcutaneous administration of amifostine for the prevention of radiation-induced toxicities
Secondary Outcomes (1)
Secondary endpoints: Evaluate efficacy of amifostine in reducing radiation induced toxicities in these patients
Interventions
Eligibility Criteria
You may qualify if:
- Patient is eligible to receive subcutaneous amifostine under site's current practice guidelines for radioprotection.
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2
- Age \> 18
- Patient receiving radiation therapy or combined modality therapy to treat malignancy.
- No evidence of distant metastatic disease.
- Granulocyte count (segs \& bands) \> 2000/mm3 and platelet count \> 100,000/mm3
- Serum creatinine \<2.0mg/dL
- Total bilirubin \<2.0mg%, SGOT \< times the upper limit of normal.
- Patients may not be entered on investigational therapeutic trials.
- Patients or guardians must be informed of and understand the investigational nature of this study and give written informed consent prior to any study procedures.
You may not qualify if:
- Life expectancy of \<6 months
- Patients receiving only chemotherapy to treat malignancy.
- Patients who have been treated with any investigational drugs \<4 weeks prior to study entry.
- General medical or psychological conditions which would not permit the patient to complete the study or sign the informed consent.
- Pregnancy; Women of childbearing potential should use an effective (for them) method of birth control throughout their participation in this study.
- Patients who are currently receiving or have received amifostine for radioprotection within the prior 6 months are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Dale & Frances Hughes Cancer Centerlead
- MedImmune LLCcollaborator
Study Sites (1)
The Dale & Frances Hughes Cancer Center
East Stroudsburg, Pennsylvania, 18301, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J. Greenberg, M.D.
The Dale & Frances Hughes Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 12, 2005
First Posted
August 15, 2005
Study Start
June 1, 2003
Study Completion
September 1, 2004
Last Updated
September 27, 2005
Record last verified: 2005-08