Evidence map›Paper›PMID 21292687›Full record

Trial reportNeuro-oncology2011

A phase II study of gefitinib and irradiation in children with newly diagnosed brainstem gliomas: a report from the Pediatric Brain Tumor Consortium.

Ian F Pollack, Clinton F Stewart, Mehmet Kocak, Tina Young Poussaint, Alberto Broniscer, Anu Banerjee, James G Douglas, Larry E Kun, James M Boyett, J Russell Geyer

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in 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 trial NCT03620032 (Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed), which is not on this map. Cited by 66 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 2 pooled it
7.5field-weighted citation impact, top 2% 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.

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

66 citing papers in PubMed, 2 syntheses or guidelines pooled it, 126 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Review
  12. Review
  13. Article
  14. Review
  15. Contemporary Management of Pediatric Brainstem Tumors.Advances and technical standards in neurosurgery · 2024
    Review
  16. Fifty years of DIPG: looking at the future with hope.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2023
    Review
  17. Radiotherapy and radio-sensitization in H3CNS neuroscience & therapeutics · 2023
    Review
  18. Review
  19. Review
  20. Pediatric Diffuse Midline Gliomas: An Unfinished Puzzle.Diagnostics (Basel, Switzerland) · 2022
    Review

6 more citing papers are in PubMed but not listed here.

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

10 authors at 3 institutions in 1 country.

Ian F PollackDepartment of Neurosurgery, Children's Hospital of Pittsburgh, 4401 Penn Avenue, Pittsburgh, PA 15224, USA. pollackif@upmc.edu
Clinton F Stewart
Mehmet Kocak
Tina Young Poussaint
Alberto Broniscer
Anu Banerjee
James G Douglas
Larry E Kun
James M Boyett
J Russell Geyer
St. Jude Children's Research Hospital · USChildren's Hospital of Pittsburgh · USSeattle Children's Hospital · US

Funding

The Pediatric Brain Tumor Consortium (PBTC)U01CA081457 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI BOYETT, JAMES MILFORD · 1999 to 2013
$29.2M
NCI NIH HHS U01 CA81457
6 · The paper itself

Abstract

This phase II study was designed to assess the safety and efficacy of gefitinib given with and following radiation therapy in children newly diagnosed with a poor prognosis brainstem glioma. Eligible patients were those with a previously untreated nondisseminated diffuse intrinsic brainstem glioma. Histological confirmation was not required, provided patients had a characteristic clinical history and MRI findings. Treatment consisted of gefitinib, administered orally, 250 mg/m(2)/day, during standard external beam radiotherapy, continuing for up to 13 monthly courses in the absence of disease progression or unacceptable toxicity. Toxicities, particularly intratumoral hemorrhage, were monitored. Pharmacokinetics and investigational imaging studies were performed in consenting patients. Forty-three eligible patients were included in the study. Therapy was well tolerated; only 4 patients were withdrawn from the study for dose-limiting toxicity after receiving therapy for 6, 9, 17, and 24 weeks. The 12- and 24-month progression-free survival rates were 20.9 ±5.6 % and 9.3 ±4%, respectively. Overall survival rates were 56.4 ±7.6% and 19.6 ±5.9%, respectively, which appear nominally superior to other contemporaneous Pediatric Brain Tumor Consortium trials. Three patients remain progression-free survivors with ≥36 months follow-up. The observation that a subset of children with this generally fatal tumor experienced long-term progression-free survival, coupled with recent observations regarding the molecular features of brainstem gliomas, raises the possibility that prospective molecular characterization may allow enrichment of treatment responders and improvement in outcome results in future studies of biologically targeted agents.

Indexed as

AdolescentAdultAntineoplastic AgentsBrain Stem NeoplasmsChildChild, PreschoolClinical Trials, Phase I as TopicCombined Modality TherapyFemaleGefitinibGliomaHumansMagnetic Resonance ImagingMaleMaximum Tolerated DoseQuinazolinesAntineoplastic AgentsGefitinibQuinazolines

Identifiers

PMID21292687
PMCPMC3064605
OpenAlexW2172048339

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.