Evidence map›Paper›PMID 29879079›Full record

Trial reportMedicine2018

Treatment rationale and design of the RAMNITA study: A phase II study of the efficacy of docetaxel + ramucirumab for non-small cell lung cancer with brain metastasis.

Keiko Tanimura, Junji Uchino, Nobuyo Tamiya, Yoshiko Kaneko, Tadaaki Yamada, Kenichi Yoshimura, Koichi Takayama

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Treatment Sequencing Strategies in Lung Cancer.Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2022
    Article
  2. Article
  3. Review
  4. Article
  5. Review
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

7 authors.

Keiko TanimuraDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto Department of Biostatistics, Innovative Clinical Research Center, Kanazawa University, Kanazawa, Ishikawa, Japan.
Junji Uchino
Nobuyo Tamiya
Yoshiko Kaneko
Tadaaki Yamada
Kenichi Yoshimura
Koichi Takayama

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe described the treatment rationale and procedure for a phase II study of docetaxel plus ramucirumab for non-small cell lung cancer (NSCLC) patients with brain metastasis (RAMNITA study: University Information Network Clinical Trials Registry identification no. [UMIN]: 000024551). Combination therapy of angiogenetic inhibitor with chemotherapy improved the outcome of patients with brain metastasis in previous reports; however, the efficacy of ramucirumab, a vascular endothelial growth factor receptor-2 monoclonal antibody, for brain metastasis has not been shown. PATIENTS AND

methodsThis RAMNITA study is a prospective, multicenter, open-label, single-arm phase II study designed to evaluate efficacy and safety of docetaxel and ramucirumab for advanced NSCLC patients with brain metastasis. Eligible patients will receive docetaxel (60 mg/m) and ramucirumab (10 mg/kg) every 21 days until disease progression. The primary endpoint is progression-free survival (PFS), and secondary endpoints are overall survival, intracranial PFS, response rate, and safety. Sixty-five participants will be recruited from September 2017 to December 2019 and followed up for 1 year after final registration. The results from this study may suggest a treatment option for brain metastasis in NSCLC. ETHICS: The protocol was approved by the institutional review board of each study center. Written informed consent will be obtained from all patients before registration, in accordance with the Declaration of Helsinki.

Indexed as

Antibodies, MonoclonalBrain NeoplasmsCarcinoma, Non-Small-Cell LungTaxoidsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrainClinical Trials, Phase II as TopicDisease-Free SurvivalDisease ProgressionDocetaxelFemaleAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsDocetaxelRamucirumabTaxoidsVascular Endothelial Growth Factor Receptor-2

Identifiers

PMID29879079
PMCPMC5999517

What OpenQuestion holds

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LicenceCC BY
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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.