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

NCT02383901 | Completed

• 1 other identifier: ISO-MTX-OB1
• Study Type: observational
• Target: 116
• Locations: 4 countries
• Sites: 5

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.

Conditions

Osteosarcoma

Outcome Measures

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.

  Druing the MAP treatment approx 30 weeks

Secondary Outcomes (6)

• 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

Interventions

Methotrexate DRUG

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Isofol Medical AB: lead

Study Sites (5)

Semmelweis Egyetem II. Sz. Gyermekklinika

Budapest, 1094, Hungary

Location

Oslo University Hospital

Oslo, N-0424, Norway

Location

Intytut Matki Dziecka Klinika Chirurgii Onkologicznej Dzieci i Młodzieży

Warsaw, 01 211, Poland

Location

Skåne University Hospital

Lund, 221 85, Sweden

Location

Karolinska University Hospital, Sweden

Stockholm, SE-17176, Sweden

Location

MeSH Terms

Conditions

Osteosarcoma

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mikael Eriksson, MD PhD.

  Skåne Universitiy Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: March 10, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: May 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (1); NO (1); HU (1); SE (2)