Evidence map›Paper›PMID 28849310›Full record

Trial reportJournal of neuro-oncology2017

Health-related quality of life, cognitive screening, and functional status in a randomized phase III trial (EF-14) of tumor treating fields with temozolomide compared to temozolomide alone in newly diagnosed glioblastoma.

Jay-Jiguang Zhu, Petya Demireva, Andrew A Kanner, Susan Pannullo, Maximilian Mehdorn, Nicholas Avgeropoulos, Andrea Salmaggi, Antonio Silvani, Samuel Goldlust, Carlos David and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of neuro-oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00916409 (A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.), which is not on this map. Cited by 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
3.4field-weighted citation impact, top 7% 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.

NCT00916409 phase3completednot on this map

A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

TypeinterventionalSponsorNovoCure Ltd.Ran2009 to 2017Enrolled700ConditionsGlioblastoma MultiformeArmsNovoTTF-100A device, Temozolomide
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 4 syntheses or guidelines pooled it, 64 citations in OpenAlex.

  1. Pooled it
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  5. Trial
  6. Methodology of analysis of cognitive impairment in longitudinal randomized clinical trials in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  7. Neuromodulation in Neuro-Oncology: A Scoping Review.Journal of personalized medicine · 2026
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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

12 authors at 8 institutions in 5 countries.

Jay-Jiguang ZhuMcGovern Medical School and Memorial Hermann Hospital at Texas Medical Center, University of Texas Health Science Center at Houston, Houston, TX, USA. jay.jiguang.zhu@uth.tmc.edu.ORCID http://orcid.org/0000-0003-4635-0914
Petya DemirevaTIRR Memorial Hermann, Houston, TX, USA.
Andrew A KannerRabin Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
Susan PannulloNew York Presbyterian Hospital-Weill Cornell Medical Center, New York, NY, USA.
Maximilian MehdornChristian-Albrechts-University of Kiel, Kiel, Germany.
Nicholas AvgeropoulosUnivresity of Florida Health Cancer Center, Orlando, FL, USA.
Andrea SalmaggiIstituto Neurologico C. Besta, Milano, Italy.
Antonio SilvaniFoundation Neurological Institute "C. Besta", Milan, Italy.
Samuel GoldlustHackensack University Medical Center, Hackensack, USA.
Carlos DavidLahey Clinic, Burlington, MA, USA.
Alexandra Benouaich-AmielHopitaux de Toulouse Purpan Pole Neurosciences PPR, Toulouse, France.
Zvi Ram on behalf of the EF-14 Trial Investigators
Lahey Hospital and Medical Center · USMemorial Hermann · USNewYork–Presbyterian Hospital · USUniversity of Florida Health · USFondazione IRCCS Istituto Neurologico Carlo Besta · ITHackensack University Medical Center · USHôpital Purpan · FRMemorial Hermann Institute for Rehabilitation and Research Foundation · US

Funding

Novocure NCT00916409
6 · The paper itself

Abstract

We characterized health-related quality of life (HRQoL), cognitive, and functional status in newly diagnosed glioblastoma (GBM) patients receiving Tumor treating fields (TTFields) with temozolomide (TMZ) versus TMZ alone in a planned interim analysis of a randomized phase III trial [NCT00916409], which showed significant improvement in progression-free and overall survival with TTFields/TMZ. After radiotherapy with concomitant TMZ, newly diagnosed GBM patients were randomized (2:1) to TTFields/TMZ (n = 210) or TMZ (n = 105). Interim analysis was performed in 315 patients with ≥18 months of follow-up. HRQoL, a secondary endpoint, was evaluated in per-protocol patient population and expressed as change from baseline (CFB) at 3, 6, and 9 months for each subscale in the EORTC QLQ-C30/BN20. Karnofsky performance scores (KPS) and Mini-Mental State Examination scores (MMSE) were assessed. CFB in HRQoL was balanced in treatment groups at the 12-month time point. Initially, HRQoL improved in patients treated with TTFields/TMZ (CFB3: 24% and CFB6: 13%) versus TMZ (CFB3: -7% and CFB6: -17%), though this difference was no longer evident at the 9-month point. General scales, including physical and social functioning, showed no difference at 9 and 12 months. TTFields/TMZ group reported higher concerns of "itchy skin". KPS over 12 months was just below 90 in both groups. Cognitive status (MMSE) was stable over time. HRQoL, KPS, and MMSE were balanced in both groups over time. There was no preliminary evidence that HRQoL, cognitive, and functional status is adversely affected by the continuous use of TTFields.

Indexed as

Electric Stimulation TherapyQuality of LifeAdultAgedAged, 80 and overAntineoplastic Agents, AlkylatingBrain NeoplasmsCognitionCombined Modality TherapyCross-Over StudiesDacarbazineFemaleFollow-Up StudiesGlioblastomaHumansKarnofsky Performance StatusAntineoplastic Agents, AlkylatingDacarbazineTemozolomideCognitionEF-14GlioblastomaHealth-related quality of life (HRQoL)TemozolomideTumor treating fields

Identifiers

PMID28849310
PMCPMC5700237
OpenAlexW2746529640

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.