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Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma


Phase 3
6 Years
18 Years
Not Enrolling
Both
Osteosarcoma

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Trial Information

Assessing the Safety, Feasibility, Cost Effectiveness and Patient Satisfaction of Outpatient Administration of High Dose Methotrexate (HD MTX) in Patients With Osteosarcoma


High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main
toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to
deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring
of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required
supportive care needs, HDMTX has historically been given as an inpatient. In some centers
however, HDMTX is being given safely as an outpatient in order to reduce health care costs,
improve patient quality of life and to deliver timely therapy with limited inpatient
chemotherapy beds available.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of outpatient High Dose Methotrexate courses which result in an inpatient hospital admission.

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Eleanor Hendershot, MN NP-Peds

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Hospital for Sick Children, Toronto Canada

Authority:

Canada: Health Canada

Study ID:

1000018144

NCT ID:

NCT01176981

Start Date:

October 2010

Completion Date:

September 2012

Related Keywords:

  • Osteosarcoma
  • pediatrics
  • Osteosarcoma
  • Methotrexate
  • Outpatient
  • Osteosarcoma

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