Evidence map›Paper›PMID 20694800›Full record

Trial reportJournal of neuro-oncology2011

High dose methotrexate for pediatric high grade glioma: results of the HIT-GBM-D pilot study.

Johannes E Wolff, Rolf-Dieter Kortmann, Birte Wolff, Torsten Pietsch, Ove Peters, Hans-Joerg Schmid, Stefan Rutkowski, Monika Warmuth-Metz, Christoph Kramm

2 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00278278 phase3unknown statusnot on this map

Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma

TypeinterventionalSponsorGerman Society for Pediatric Oncology and Hematology GPOH gGmbHRan2003Enrolled150ConditionsBrain and Central Nervous System TumorsArmscisplatin, etoposide, ifosfamide, lomustine, methotrexate
NCT03620032 phase2unknown statusnot on this mapstarted 2015, after this paper: background citation

Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2015 to 2024Enrolled54ConditionsDiffuse Intrinsic Pontine GliomaArmsNimotuzumab, Vinorelbine, Radiotherapy
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 54 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Does the interval from tumour surgery to radiotherapy influence survival in paediatric high grade glioma?Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2018
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. The effect of ABCG2 and ABCC4 on the pharmacokinetics of methotrexate in the brain.Drug metabolism and disposition: the biological fate of chemicals · 2014
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 8 institutions in 2 countries.

Johannes E WolffDivision of Pediatrics, Unit 87, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. jwolff@mdanderson.org
Rolf-Dieter Kortmann
Birte Wolff
Torsten Pietsch
Ove Peters
Hans-Joerg Schmid
Stefan Rutkowski
Monika Warmuth-Metz
Christoph Kramm
Baylor College of Medicine · USBoston Children's Hospital · USLeipzig University · DESt. Hedwig-Krankenhaus · DETufts Medical Center · USUniversität Hamburg · DEUniversity of Bonn · DEUniversity of Würzburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We conducted a phase II study to test methotrexate (5 g/m(2)), as a single agent prior to radiochemotherapy for pediatric high-grade glioma and diffuse intrinsic pontine glioma. Thirty patients (19 male, median age 10.8) were enrolled. Tumors were located as follows: cortex 10, pons 7, other 13. Tumor resection was classified as gross total in 6, subtotal in 6, partial in 4, biopsy in 11 and not performed in 3. WHO grading of the histology was: IV: 11, III: 12 and II: 3. Patients received methotrexate 5 g/m(2) in 24-hour infusions on days 1 and 15. Subsequently 54 Gy radiation was administered with simultaneous chemotherapy including cisplatin, etoposide, vincristine and ifosfamide as previously described. Eight 6-weeks cycles of maintenance chemotherapy consisted of vincristine 1.5 mg/m(2) on days 1, 8 and 15; lomustine 100 mg/m(2) on day 2 and prednisone 40 mg/kg on days 1-17. Event-free survival rates in the whole group of 30 patients were: 43, 20, and 13% after 1, 2 and 5 years, respectively. The response evaluation after methotrexate was available in 19 of the 24 patients who started treatment with measurable disease: CR: 0, PR: 1, SD 18, PD: 0. After radiochemotherapy the response of 24 patients with measurable disease was CR: 1, PR 10, SD 12, PD 1. Both response and event-free survival were superior to the control group of 330 patients treated in various protocols of the same cooperative group. In subgroup analyses the use of dexamethasone during early treatment was linked to poor event free survival. Giving two cycles of high-dose methotrexate prior to radiochemotherapy was feasible, and the approach was taken forward to a randomized phase III trial.

Indexed as

AdolescentBrain NeoplasmsChildChild, PreschoolChi-Square DistributionCohort StudiesDose-Response Relationship, DrugFemaleGliomaHumansImmunosuppressive AgentsMaleMethotrexatePilot ProjectsSurvival AnalysisTreatment OutcomeImmunosuppressive AgentsMethotrexate

Identifiers

PMID20694800
OpenAlexW1987719316

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.