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

Osteosarcoma Clinical Trial

— FORTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383901
• Other study ID #: ISO-MTX-OB1
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: September 2, 2016
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Isofol Medical AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis Egyetem II. Sz. Gyermekklinika	Budapest
Norway	Oslo University Hospital	Oslo
Poland	Intytut Matki Dziecka Klinika Chirurgii Onkologicznej Dzieci i Mlodziezy	Warszawa
Sweden	Skåne University Hospital	Lund
Sweden	Karolinska University Hospital, Sweden	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Isofol Medical AB

Countries where clinical trial is conducted

Hungary,  Norway,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Number of patients with MTX excretion toxicity		Druing the MAP treatment approx 30 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Characterization of the S-MTX elimination profile and management		Druing the MAP treatment approx 30 weeks	Yes