Evidence map›Paper›PMID 28915900›Full record

Trial reportTrials2017

A randomized phase II study to assess the effect of adjuvant immunotherapy using α-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer: study protocol for a randomized controlled trial.

Hideo Saka, Chiyoe Kitagawa, Yukito Ichinose, Mitsuhiro Takenoyama, Hidenori Ibata, Tatsuo Kato, Koji Takami, Motohiro Yamashita, Tadashi Maeda, Sadanori Takeo and 10 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 27% 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.

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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Adoptive cell therapies in thoracic malignancies.Cancer immunology, immunotherapy : CII · 2022
    Review
  6. Review
  7. Article
  8. Targeting Sphingolipids for Cancer Therapy.Frontiers in oncology · 2021
    Review
  9. Immune cell engineering: opportunities in lung cancer therapeutics.Drug delivery and translational research · 2020
    Review
  10. Review
  11. Article
  12. Article
  13. 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

20 authors at 11 institutions in 1 country.

Hideo SakaDepartment of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi, Japan. saka@med.nagoya-u.ac.jp.
Chiyoe KitagawaDepartment of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Yukito IchinoseDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Mitsuhiro TakenoyamaDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Hidenori IbataDepartment of Respiratory Medicine, National Hospital Organization Mie Chuo Medical Center, Mie, Japan.
Tatsuo KatoDepartment of Respiratory Medicine, National Hospital Organization Nagara Medical Center, Gifu, Japan.
Koji TakamiDepartment of Respiratory Medicine, National Hospital Organization Osaka Medical Center, Osaka, Japan.
Motohiro YamashitaDepartment of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
Tadashi MaedaDepartment of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center, Yamaguchi, Japan.
Sadanori TakeoDepartment of Thoracic Surgery, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Hitoshi UedaDepartment of Surgery, National Hospital Organization Fukuoka Hospital, Fukuoka, Japan.
Kan OkabayashiDepartment of Thoracic Surgery, National Hospital Organization Fukuoka Higashi Medical Center, Fukuoka, Japan.
Seiji NagashimaDepartment of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan.
Tadayuki OkaDepartment of Surgery, National Hospital Organization Ureshino Medical Center, Saga, Japan.
Hidenori KousoDepartment of Thoracic Surgery, National Hospital Organization Oita Medical Center, Oita, Japan.
Seiichi FukuyamaDepartment of Thoracic Surgery, National Hospital Organization Beppu Medical Center, Oita, Japan.
Kentaro YoshimotoDepartment of Thoracic Surgery, National Hospital Organization Minami Kyushu National Hospital, Kagoshima, Japan.
Mototsugu ShimokawaClinical Research Center, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Akiko M SaitoClinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Suminobu ItoClinical Research Center, National Hospital Organization, Tokyo, Japan.
National Hospital Organization · JPNagoya Medical Center · JPNational Hospital Organization Kyushu Cancer Center · JPBeppu Medical Center · JPFukuoka Higashi Medical Center · JPNagasaki Medical Center · JPNational Kyushu Medical Center · JPNational Sanyo Hospital · JPOsaka National Hospital · JPShikoku Cancer Center · JPUreshino Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs the toxicity associated with the α-GalCer-pulsed dendritic cell (DC) therapy could be considered to be negligible, its addition to postoperative adjuvant chemotherapy would be expected to greatly improve the therapeutic effect, and could result in prolonged survival. The aim of the present study is to compare the therapeutic efficacy of alpha-galactosylceramide-pulsed DC therapy in patients who have undergone a complete resection of stage II-IIIA non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant therapy with cisplatin plus vinorelbine, to that in patients who did not receive additional treatment (surgical resection plus postoperative adjuvant chemotherapy only).

methodsSubsequent to the complete resection of NSCLC, followed by the administration of cisplatin plus vinorelbine dual-agent combination adjuvant chemotherapy, patients who satisfy the inclusion criteria will be randomly allocated to either the α-GalCer-pulsed DC immune therapy group, or the standard treatment group. In total, 56 patients will be included in the study. The primary endpoint is recurrence-free survival, and the secondary endpoints are natural killer T-cell-specific immune response, the frequency of toxic effects and safety, and overall survival. DISCUSSION: In order to determine the efficacy of α-GalCer-pulsed DC therapy, the present study compares patients with stage II-III NSCLC who underwent complete surgical resection followed by postoperative adjuvant therapy with cisplatin plus vinorelbine, to those who did not receive additional treatment (surgical resection plus postoperative adjuvant chemotherapy only).

trial registrationUMIN000010386 ( R000012145 ). Registered on 1 April 2013. UMIN-CTR is officially recognized as a registration site which satisfies ICMJE criteria.

Indexed as

PneumonectomyAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantCisplatinClinical ProtocolsDendritic CellsDisease-Free SurvivalFemaleGalactosylceramidesHumansImmunotherapy, AdoptiveJapanLung Neoplasmsalpha-galactosylceramideCisplatinGalactosylceramidesVinblastineVinorelbineImmunotherapyNon-small cell lung cancerPhase II

Identifiers

PMID28915900
PMCPMC5603008
OpenAlexW2755243171

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.