Evaluating high-dose methotrexate treatment in cancer patients
High-dose Methotrexate Patterns of Use, Clearance, Toxicities, Supportive Care and Outcomes
This study looks at how high-dose methotrexate is used in cancer patients to see if current practices match guidelines and to understand any side effects or differences in treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | BTG International Inc. Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 5 sites (Marseille and 4 other locations) |
| Trial ID | NCT05899751 on ClinicalTrials.gov |
What this trial studies
This observational study reviews the use of high-dose methotrexate in cancer patients, focusing on patterns of administration, supportive care measures, and the incidence of delayed methotrexate elimination and acute kidney injury. It aims to compare current practices against established guidelines to identify gaps in management and variations in outcomes across different centers and patient demographics. The study will also document the use of glucarpidase and any associated toxicities during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults and children diagnosed with any type of cancer who have received high-dose methotrexate chemotherapy.
Not a fit: Patients who have not received high-dose methotrexate or those without available medical records will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of high-dose methotrexate therapy, potentially reducing the risk of acute kidney injury and enhancing treatment outcomes for cancer patients.
How similar studies have performed: Other studies have explored high-dose methotrexate treatment, but this study aims to provide a comprehensive evaluation of current practices, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A diagnosis of any cancer from January 1, 2001 to June 30, 2021. * Receipt of high-dose methotrexate chemotherapy, defined as a dose of 500 mg/m2 of body surface area or higher. * Medical records available for review. * Any age; any cancer type. Exclusion Criteria: * None.
Where this trial is running
Marseille and 4 other locations
- Assistance Publique Hôpitaux de Marseille (APHM), La Timone Hospital — Marseille, France (Recruiting)
- University of Milan-Bicocca — Monza, Italy (Recruiting)
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR) — Barcelona, Spain (Recruiting)
- Fundación Privada Instituto de Investigación Oncológica de Vall d'Hebron (VHIO) — Barcelona, Spain (Recruiting)
- Hospital Universitario Reina Sofía — Córdoba, Spain (Recruiting)
Study contacts
- Principal investigator: Carmelo Rizzari, MD — University of Milano-Bicocca, Pediatric Hematology Oncology Unit MBBM Foundation
- Study coordinator: Lois Wallace
- Email: Lois.wallace@btgsp.com
- Phone: +1 945 239 1690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.