Osteosarcoma Clinical Trial
Official title:
Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma
Verified date | October 2021 |
Source | The Hospital for Sick Children |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: - = 6 years of age; - Localized or metastatic osteosarcoma; - Adequate renal function (GFR > 70 ml/1.73m2) prior to each cycle; - No grade III/IV renal toxicity, mucositis or vomiting with most recent prior inpatient MTX cycle; - Parent and/or patient must be able to provide written consent, and complete Patient Flow Sheets in English. Exclusion Criteria: - Patients, in the opinion of the primary healthcare team, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal. - Pregnant females - Breastfeeding females |
Country | Name | City | State |
---|---|---|---|
Canada | The Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Outpatient High Dose Methotrexate Courses Which Result in an Inpatient Hospital Admission. | Patients will be evaluated prior to and daily during each outpatient HDMTX course, and if one or more of a list of hospitalization criteria are met, the patient will be admitted to hospital to complete that course. | 9 months |
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