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

Completed

• Conditions: Osteosarcoma

• Registration Number: NCT02383901
• Lead Sponsor: Isofol Medical AB

Brief Summary

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.

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-10
• Primary Completion: 2015-09
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Druing the MAP treatment approx 30 weeks

Secondary Outcome Measures

Name	Time	Method
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.	Druing the MAP treatment approx 30 weeks
Number of patients with MTX excretion toxicity	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.	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.	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.	Druing the MAP treatment approx 30 weeks
Characterization of the S-MTX elimination profile and management	Druing the MAP treatment approx 30 weeks

Trial Locations

Locations (5)

Oslo University Hospital; 🇳🇴 Oslo, Norway

Semmelweis Egyetem II. Sz. Gyermekklinika; 🇭🇺 Budapest, Hungary

Karolinska University Hospital, Sweden; 🇸🇪 Stockholm, Sweden

Intytut Matki Dziecka Klinika Chirurgii Onkologicznej Dzieci i Młodzieży; 🇵🇱 Warszawa, Poland

Skåne University Hospital; 🇸🇪 Lund, Sweden