Evidence map›Paper›PMID 35346332›Full record

ArticleTrials2022

The efficacy of temozolomide combined with levetiracetam for glioblastoma (GBM) after surgery: a study protocol for a double-blinded and randomized controlled trial.

Maoyuan Sun, Ning Huang, Yihao Tao, Rong Wen, Guanjian Zhao, Xiang Zhang, Zongyi Xie, Yuan Cheng, Jinning Mao, Guodong Liu

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Article
  6. Review
  7. The effect of anticonvulsants on survival among patients with GBM brain tumors undergoing radiation: A SEER-Medicare analysis.Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2022
    Article
  8. Frontiers in oncology · 2022
    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

10 authors.

Maoyuan SunDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Ning HuangDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Yihao TaoDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Rong WenDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Guanjian ZhaoDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Xiang ZhangDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Zongyi XieDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Yuan ChengDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Jinning MaoDepartment of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China.
Guodong LiuDepartment of Neurosurgery, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400000, China. 304678@hospital.cqmu.edu.cn.ORCID http://orcid.org/0000-0002-8048-2243

Funding

Chongqing Scientific and Health Joint Medical Research Project 2020GDRC021
6 · The paper itself

Abstract

backgroundTemozolomide is applied as the standard chemotherapy agent in patients with glioblastoma (GBM) after surgery. However, the benefit of this treatment for patients is limited by the invasive growth of gliomas and drug resistance. There are indications from fundamental experimental and retrospective studies that levetiracetam has the potential to improve the survival rate of patients with GBM. However, it has yet to be determined whether the combination of temozolomide and levetiracetam is more effective than standard temozolomide chemotherapy. Therefore, we designed a randomized clinical trial to investigate the therapeutic effect of the new combined regime for treating GBM. METHODS/

designThis is a double-blind and randomized clinical trial conducted in a single center. One hundred forty-two patients will be recruited and screened for the inclusion and exclusion criteria. Then, eligible participants will be randomly assigned to an experimental group or a control group in a 1:1 ratio. Based on the administration of radiation therapy (RT), participants in the experimental group will be prescribed levetiracetam plus temozolomide chemotherapy for 34 weeks while participants in the control group will receive placebo tablets plus temozolomide for the same duration. A 3-year follow-up will be conducted on all patients after intervention. Accordingly, the primary outcome will be progression-free survival (PFS). The secondary endpoints include overall survival (OS), the Karnofsky Performance Status (KPS), the objective response rate (ORR), and adverse event incidence. DISCUSSION: It is expected that the results of this trial will provide high-level evidence regarding the clinical benefits of levetiracetam and temozolomide combined in the treatment of GBM.

trial registrationChinese Clinical Trial Registry, ChiCTR2100049941 . Registered on 14 August 2021.

Indexed as

Brain NeoplasmsGlioblastomaAntineoplastic Combined Chemotherapy ProtocolsHumansLevetiracetamRandomized Controlled Trials as TopicRetrospective StudiesTemozolomideLevetiracetamTemozolomideChemotherapyClinical trialGlioblastoma (GBM)Temozolomide, Levetiracetam

Identifiers

PMID35346332
PMCPMC8962067

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Registered trials

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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.