Evidence map›Paper›PMID 26686362›Full record

Trial reportBMC cancer2015

A randomized phase II study of radiation induced immune boost in operable non-small cell lung cancer (RadImmune trial).

Seyer Safi, Philipp Beckhove, Arne Warth, Axel Benner, Falk Roeder, Stefan Rieken, Juergen Debus, Hendrik Dienemann, Hans Hoffmann, Peter E Huber

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02319408 (A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer), which is not on this 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.

NCT02319408 nacompletednot on this mapstarted 2016, after this paper: background citation

A Randomized Phase II Study of Radiation Induced Immune Boost in Operable Non-small Cell Lung Cancer

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2016 to 2020Enrolled36ConditionsNon-small Cell Lung CancerArmsPreoperative radiation
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Ultra-high dose-rate proton FLASH improves tumor control.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2023
    Article
  2. Function of BCLAF1 in human disease.Oncology letters · 2022
    Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. 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

10 authors.

Seyer SafiDepartment of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany. seyer.safi@med.uni-heidelberg.de.
Philipp BeckhoveTranslational Immunology Unit, German Cancer Research Center, Heidelberg, Germany. p.beckhove@dkfz.de.
Arne WarthDivision of Thoracic Pathology, Institute of Pathology, Heidelberg, Germany. arne.warth@med.uni-heidelberg.de.
Axel BennerDivision of Biostatistics, German Cancer Research Center, Heidelberg, Germany. a.benner@dkfz.de.
Falk RoederDepartments of Molecular and Radiation Oncology, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany. Falk.Roeder@med.uni-muenchen.de.
Stefan RiekenDepartments of Molecular and Radiation Oncology, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany. stefan.rieken@med.uni-heidelberg.de.
Juergen DebusDepartments of Molecular and Radiation Oncology, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany. juergen.debus@med.uni-heidelberg.de.
Hendrik DienemannDepartment of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany. hendrik.dienemann@med.uni-heidelberg.de.
Hans HoffmannDepartment of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany. hans.hoffmann@med.uni-heidelberg.de.
Peter E HuberDepartments of Molecular and Radiation Oncology, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany. p.huber@dkfz.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLung cancer is the leading cause of cancer deaths worldwide. Surgery, radiotherapy at conventional and high dose and chemotherapy are the mainstay for lung cancer treatment. Insufficient migration and activation of tumour specific effector T cells seem to be important reasons for inadequate host anti-tumour immune response. Ionizing radiation can induce a variety of immune responses. The goal of this randomized trial is to assess if a preoperative single fraction low dose radiation is able to improve anti-tumour immune response in operable early stage lung cancer. METHODS/

designThis trial has been designed as an investigator-initiated, prospective, randomized, 2-armed phase II trial. Patients who are candidates for elective resection of early stage non-small cell lung cancer will be randomized into 2 arms. A total of 36 patients will be enrolled. The patients receive either 2 Gy or no radiation prescribed to their primary tumour. Radiation will be delivered by external beam radiotherapy using 3D radiotherapy or intensity-modulated radiation technique (IMRT) 7 days prior to surgical resection. The primary objective is to compare CD8+ T cell counts detected by immunohistochemistry in resected tumours following preoperative radiotherapy versus no radiotherapy. Secondary objectives include the association between CD8+ T cell counts and progression free survival, the correlation of CD8+ T cell counts quantified by immunohistochemistry and flow cytometry, local tumour control and recurrence patterns, survival, radiogenic treatment toxicity and postoperative morbidity and mortality. Further, frequencies of tumour reactive T cells in blood and bone marrow as well as whole blood cell transcriptomics and plasma-proteomics will be correlated with clinical outcome. DISCUSSION: This unique intervention combining preoperative low dose radiation and surgical removal of early stage non-small cell lung cancer is designed to address the problem of inadequate host anti-tumour immune response. If successful, this study may affect the role of radiotherapy in lung cancer treatment.

trial registrationNCT02319408; REGISTRATION: December 29, 2014.

Indexed as

Carcinoma, Non-Small-Cell LungCD8-Positive T-LymphocytesFollow-Up StudiesHumansImmunity, CellularLung NeoplasmsProspective StudiesRadiotherapy, Intensity-Modulated

Identifiers

PMID26686362
PMCPMC4684916

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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.