We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    02383901
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02383901
First Posted: March 10, 2015
Last Update Posted: September 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Isofol Medical AB
  Purpose
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.

Condition Intervention
Osteosarcoma Drug: Methotrexate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Non-intervention Study to Characterize FOlate Rescue Treatment in Osteosarcoma Patients Treated With HDMTX

Resource links provided by NLM:


Further study details as provided by Isofol Medical AB:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • Number of patients with MTX excretion toxicity [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Characterization of the S-MTX elimination profile and management [ Time Frame: Druing the MAP treatment approx 30 weeks ]

Enrollment: 116
Study Start Date: September 2014
Study Completion Date: May 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Methotrexate
    The study includes osteosarcoma patients who have received MAP treatment, MAP treatment contains 12 courses of Methotrexate
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383901


Locations
Hungary
Semmelweis Egyetem II. Sz. Gyermekklinika
Budapest, Hungary, 1094
Norway
Oslo University Hospital
Oslo, Norway, N-0424
Poland
Intytut Matki Dziecka Klinika Chirurgii Onkologicznej Dzieci i Młodzieży
Warszawa, Poland, 01 211
Sweden
Skåne University Hospital
Lund, Sweden, 221 85
Karolinska University Hospital, Sweden
Stockholm, Sweden, SE-17176
Sponsors and Collaborators
Isofol Medical AB
Investigators
Principal Investigator: Mikael Eriksson, MD PhD. Skåne Universitiy Hospital
  More Information

Responsible Party: Isofol Medical AB
ClinicalTrials.gov Identifier: NCT02383901     History of Changes
Other Study ID Numbers: ISO-MTX-OB1
First Submitted: October 29, 2014
First Posted: March 10, 2015
Last Update Posted: September 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication in relevant forum planned after finalization of study report

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors