Evidence map›Paper›PMID 25910950›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015

A Multicenter, Phase II, Randomized, Noncomparative Clinical Trial of Radiation and Temozolomide with or without Vandetanib in Newly Diagnosed Glioblastoma Patients.

Eudocia Q Lee, Thomas J Kaley, Dan G Duda, David Schiff, Andrew B Lassman, Eric T Wong, Tom Mikkelsen, Benjamin W Purow, Alona Muzikansky, Marek Ancukiewicz and 14 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 14 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 14 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Molecular Biomarkers in Glioblastoma: A Systematic Review and Meta-Analysis.International journal of molecular sciences · 2022
    Pooled it
  8. Pooled it
  9. Anti-epidermal growth factor receptor therapy for glioblastoma in adults.The Cochrane database of systematic reviews · 2020
    Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Anti-angiogenic therapy for high-grade glioma.The Cochrane database of systematic reviews · 2018
    Pooled it
  14. Pooled it
  15. Trial
  16. Trial
  17. Next-generation therapeutics for glioblastoma: Challenges and future directions.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  18. Review
  19. Article
  20. Review

9 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

24 authors.

Eudocia Q LeeDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.
Thomas J KaleyMemorial Sloan Kettering Cancer Center, New York, New York.
Dan G DudaHarvard Medical School, Boston, Massachusetts. Massachusetts General Hospital, Boston, Massachusetts.
David SchiffUniversity of Virginia, Charlottesville, Virginia.
Andrew B LassmanNew York-Presbyterian Hospital/Columbia University Medical Center, New York, New York.
Eric T WongHarvard Medical School, Boston, Massachusetts. Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Tom MikkelsenHenry Ford Hospital, Detroit, Michigan.
Benjamin W PurowUniversity of Virginia, Charlottesville, Virginia.
Alona MuzikanskyHarvard Medical School, Boston, Massachusetts. Massachusetts General Hospital, Boston, Massachusetts.
Marek AncukiewiczMassachusetts General Hospital, Boston, Massachusetts.
Jason T HuseMemorial Sloan Kettering Cancer Center, New York, New York.
Shakti RamkissoonDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.
Jan DrappatzUniversity of Pittsburgh Medical Center, Cancer Centers, Pittsburgh, Pennsylvania.
Andrew D NordenDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.
Rameen BeroukhimDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.
Stephanie E WeissFox Chase Cancer Center, Philadelphia, Pennsylvania.
Brian M AlexanderDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.
Christine S McCluskeyDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.
Mary GerardDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.
Katrina H SmithDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts.
Rakesh K JainHarvard Medical School, Boston, Massachusetts. Massachusetts General Hospital, Boston, Massachusetts.
Tracy T BatchelorHarvard Medical School, Boston, Massachusetts. Massachusetts General Hospital, Boston, Massachusetts.
Keith L LigonDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts.
Patrick Y WenDana-Farber/Brigham and Women's Cancer Center, Boston, Massachusetts. Harvard Medical School, Boston, Massachusetts. Patrick_Wen@dfci.harvard.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Vascular Normalization: Rolse of Perivascular CellsP01CA080124 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI JAIN, RAKESH K. · 2000 to 2016
$35.0M
Clinical and Molecular Studies of Novel Therapeutics in Malignant Brain TumorsK24CA125440 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI BATCHELOR, TRACY T · 2007 to 2016
$1.9M
ALK signaling in CNS development, ischemic brain injury and gliomagenesisK08NS087118 · NINDS · BRIGHAM AND WOMEN'S HOSPITAL · PI RAMKISSOON, SHAKTI H · 2014 to 2015
$387k
NCI NIH HHS K24 CA125440NCI NIH HHS P01 CA080124NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeVandetanib, a tyrosine kinase inhibitor of KDR (VEGFR2), EGFR, and RET, may enhance sensitivity to chemotherapy and radiation. We conducted a randomized, noncomparative, phase II study of radiation (RT) and temozolomide with or without vandetanib in patients with newly diagnosed glioblastoma (GBM). EXPERIMENTAL

designWe planned to randomize a total of 114 newly diagnosed GBM patients in a ratio of 2:1 to standard RT and temozolomide with (76 patients) or without (38 patients) vandetanib 100 mg daily. Patients with age ≥ 18 years, Karnofsky performance status (KPS) ≥ 60, and not on enzyme-inducing antiepileptics were eligible. Primary endpoint was median overall survival (OS) from the date of randomization. Secondary endpoints included median progression-free survival (PFS), 12-month PFS, and safety. Correlative studies included pharmacokinetics as well as tissue and serum biomarker analysis.

resultsThe study was terminated early for futility based on the results of an interim analysis. We enrolled 106 patients (36 in the RT/temozolomide arm and 70 in the vandetanib/RT/temozolomide arm). Median OS was 15.9 months [95% confidence interval (CI), 11.0-22.5 months] in the RT/temozolomide arm and 16.6 months (95% CI, 14.9-20.1 months) in the vandetanib/RT/temozolomide (log-rank P = 0.75).

conclusionsThe addition of vandetanib at a dose of 100 mg daily to standard chemoradiation in patients with newly diagnosed GBM or gliosarcoma was associated with potential pharmacodynamic biomarker changes and was reasonably well tolerated. However, the regimen did not significantly prolong OS compared with the parallel control arm, leading to early termination of the study.

Indexed as

AdultAgedAged, 80 and overCombined Modality TherapyDacarbazineDisease-Free SurvivalFemaleGlioblastomaHumansKaplan-Meier EstimateKarnofsky Performance StatusMaleMiddle AgedPiperidinesQuinazolinesTemozolomideDacarbazinePiperidinesQuinazolinesTemozolomidevandetanib

Identifiers

PMID25910950
PMCPMC4790106

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.