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Completed

NCT Number: NCT02383901

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

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.

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Key information

Conditions

Osteosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis Egyetem II. Sz. Gyermekklinika, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

The study includes osteosarcoma patients who have received MAP treatment, MAP treatment contains 12 courses of Methotrexate

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Number of patients with MTX excretion toxicity

    Time frame: Druing the MAP treatment approx 30 weeks

  3. 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

  4. 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

  5. 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

  6. Characterization of the S-MTX elimination profile and management

    Time frame: Druing the MAP treatment approx 30 weeks

Sponsors and collaborators

Lead sponsor

Isofol Medical AB

Industry

Registry information

Acronym: FORTO

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 10, 2015
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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