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Clinical trials for Methotrexate

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: The CALGB study ( C9710) was designed primarily to test the hypothesis that arsenic trioxide, when added to consolidation therapy in the treatment of newly diagnosed patients, improves patients’ event-free survival in the newly diagnosed setting. In addition, this study evaluated the benefits and risks of 2 maintenance therapy regimens (ATRA versus ATRA plus mercaptopurine [6-MP]/methotrexate [MTX]), as well as the prognostic significance of CD56 expression.
    Active substance: arsenic trioxide
    Study summary document link (including results): TrisenoxCALGBC9710.xls
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    Document reference: 47200
    Study title: POG 9006 study : A comparison of early intensive methotrexate/mercaptopurine with early intensive alternating combination chemotherapy for high-risk B-precursor acute lymphoblastic leukemia
    Active substance: ASPARAGINASE
    Study summary document link (including results):
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    Document reference: 21926
    Study title: Kellie SJ et al, Activity of postoperative carboplatin, etoposide, and high-dose methotrexate in, pediatric CNS embryonal tumors: results of a phase II study in newly diagnosed children, Med Pediatr Oncol. 2002 Sep;39(3):168-74
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26856
    Study title: Chi SN et al Feasibility and response to induction chemotherapy intensified with high-dose methotrexate for young children with newly diagnosed high-risk disseminated medulloblastoma J Clin Oncol 2004 Dec 15;22(24):4881-7. Erratum in: J Clin Oncol 2005 Apr 20;23(12):2877
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26720
    Study title: McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer 2006 Mar;46(3):345-50
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26681
    Study title: McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26786
    Study title: Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer 2007 Mar;43(4):752-61. Epub 2007 Jan 30
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26673
    Study title: Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26785
    Study title: Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30Le Deley MC et al SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients Eur J Cancer. 2007 Mar;43(4):752-61. Epub 2007 Jan 30
    Active substance: ETOPOSIDE AND IFOSFAMIDE
    Study summary document link (including results):
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    Document reference: 26967
    Study title: Cairo MS et al, Long-term follow-up of short intensive multiagent chemotherapy without high-dose methotrexate ('Orange') in children with advanced non-lymphoblastic non-Hodgkin's lymphoma: a children's cancer group report, Leukemia. 2002 Apr;16(4):594-600
    Active substance: ETOPOSIDE
    Study summary document link (including results):
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    Document reference: 26920
    Study title: Single-dose methotrexate regimen in the treatment of low-risk gestational trophoblastic neoplasia
    Active substance: DACTINOMYCIN
    Study summary document link (including results):
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    Document reference: 25461
    Study title: Chi SN et al Feasibility and response to induction chemotherapy intensified with high-dose methotrexate for young children with newly diagnosed high-risk disseminated medulloblastoma J Clin Oncol 2004 Dec 15;22(24):4881-7. Erratum in: J Clin Oncol 2005 Apr 20;23(12):2877Chi SN et al Feasibility and response to induction chemotherapy intensified with high-dose methotrexate for young children with newly diagnosed high-risk disseminated medulloblastoma J Clin Oncol 2004 Dec 15;22(24):4881-7. Erratum in: J Clin Oncol 2005 Apr 20;23(12):2877
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24826
    Study title: Cairo MS et al Long-term follow-up of short intensive multiagent chemotherapy without high-dose methotrexate ('Orange') in children with advanced non-lymphoblastic non-Hodgkin's lymphoma: a children's cancer group report Leukemia. 2002 Apr;16(4):594-600Cairo MS et al Long-term follow-up of short intensive multiagent chemotherapy without high-dose methotrexate ('Orange') in children with advanced non-lymphoblastic non-Hodgkin's lymphoma: a children's cancer group report Leukemia. 2002 Apr;16(4):594-600
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24805
    Study title: Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24
    Active substance: CYCLOPHOSPHAMIDE
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    Document reference: 24873
    Study title: Ferrari S et al Prospective evaluation of renal function in pediatric and adult patients treated with high-dose ifosfamide, cisplatin and high-dose methotrexate Anticancer Drugs. 2005 Aug;16(7):733-8Ferrari S et al Prospective evaluation of renal function in pediatric and adult patients treated with high-dose ifosfamide, cisplatin and high-dose methotrexate Anticancer Drugs. 2005 Aug;16(7):733-8
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24874
    Study title: Koch Nogueira PC et al Long-term nephrotoxicity of cisplatin, ifosfamide, and methotrexate inoteosarcoma Pediatr Nephrol. 1998 Sep;12(7):572-5Koch Nogueira PC et al Long-term nephrotoxicity of cisplatin, ifosfamide, and methotrexate inoteosarcoma Pediatr Nephrol. 1998 Sep;12(7):572-5
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24963
    Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24742
    Study title: Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24794
    Study title: Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.Brecher ML et al. Fractionated cylophosphamide and back to back high dose methotrexate and cytosinearabinoside improves outcome in patients with stage III high grade small non-cleaved cell lymphomas (SNCCL): a randomized trial of the Pediatric Oncology Group. Med Pediatr Oncol. 1997 Dec;29(6):526-33.
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 24795
    Study title: Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95. Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95.
    Active substance: CYCLOPHOSPHAMIDE
    Study summary document link (including results):
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    Document reference: 25140
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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