A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX (FORTO)

September 2, 2016 updated by: Isofol Medical AB
The purpose of this study is to investigate to which extend osteosarcoma patients do NOT meet the criteria for successfully advancement to next planned chemotherapy course.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methotrexate is one of the most effective chemotherapy drugs in the treatment of osteosarcoma. However, it has severe side effects. The physicians tries to save or "rescue" normal cells from the side effects of methotrexate by giving folinic acid. Folinic acid administration starts 24 hours after methotrexate and given regularly until methotrexate levels are low and not dangerous to normal cells anymore. Despite this rescue, side effects are still a problem and many patients are not well enough to receive subsequent chemotherapy on time.

This is a multi-center, observational retrospective study with osteosarcoma patients, 2 years of age or older, who have received at least one (1) course of HDMTX treatment with folate rescue in a MAP schedule between 01January 2009 and 31 May 2014, both dates included.

Patients must have initiated their HDMTX treatment after 01 January 2009, received at least one (1) course of HDMTX treatment with folate rescue, and received their last MAP intervention (regardless if the patients received all planned HDMTX treatments or terminated prematurely their treatment) by 31 May 2014.

Patient data collected for the study will be extracted from hospital medical records and will include information related to scheduled and/or received HDMTX courses. The collected data will include: laboratory values confirming suitability to receive next chemotherapy intervention at scheduled time, drug administration regimen (both HDMTX and supportive care), toxicity management (hydration and folate rescue regimens), and toxicity monitoring.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1094
        • Semmelweis Egyetem II. Sz. Gyermekklinika
  • Norway
      • Oslo, Norway, N-0424
        • Oslo University Hospital
  • Poland
      • Warszawa, Poland, 01 211
        • Intytut Matki Dziecka Klinika Chirurgii Onkologicznej Dzieci i Młodzieży
  • Sweden
      • Lund, Sweden, 221 85
        • Skåne University Hospital
      • Stockholm, Sweden, SE-17176
        • Karolinska University Hospital, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Osteosarcoma patients, 2 years of age or older. Patients must have received at least one course of HDMTX treatment with folate rescue in a MAP schedule. The treatment must have been initiated by 01 January 2009 and completed by 31 May, 2014

Description

Inclusion Criteria:

  • Patients must have histological evidence of osteosarcoma including metastatic osteosarcoma.
  • Patients must have initiated their HDMTX treatment after 01 January 2009 and should have completed their MAP treatment by 31 May 2014.
  • Patients should have received at least one (1) HDMTX course within MAP treatment.
  • Patients must be at least 2 years of age.
  • Patient, parent(s), or guardian(s), as appropriate, is/are willing to provide signed informed consent, if applicable according to national regulation.

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients classified as NOT having met the criteria for successful advancement from the first to second HDMTX course within the same MAP and/or next MAP cycle at scheduled time in any given HDMTX courses.
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Administrated HDMTX courses classified as NOT having met the criteria for successful advancement from first to second HDMTX course and/or from the second HDMTX course to the next MAP cycle at scheduled time.
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks
Number of patients with MTX excretion toxicity
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks
AEs and laboratory test values that resulted in change of folate management reported during the MAP cycle that led or contributed to NOT successfully advancement to next treatment at scheduled time.
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks
AEs and laboratory test values reported during the MAP cycle that led or contributed to changes in planned hydration strategy.
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks
AEs and laboratory test values reported during the MAP cycle that led or contributed to changes in planned folate rescue strategy.
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks
Characterization of the S-MTX elimination profile and management
Time Frame: Druing the MAP treatment approx 30 weeks
Druing the MAP treatment approx 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isofol Medical AB

Investigators

  • Principal Investigator: Mikael Eriksson, MD PhD., Skåne Universitiy Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

March 3, 2015

First Posted (Estimate)

March 10, 2015

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO-MTX-OB1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication in relevant forum planned after finalization of study report

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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