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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

BACKGROUND: As 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 pr...

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Autores principales: Saka, Hideo, Kitagawa, Chiyoe, Ichinose, Yukito, Takenoyama, Mitsuhiro, Ibata, Hidenori, Kato, Tatsuo, Takami, Koji, Yamashita, Motohiro, Maeda, Tadashi, Takeo, Sadanori, Ueda, Hitoshi, Okabayashi, Kan, Nagashima, Seiji, Oka, Tadayuki, Kouso, Hidenori, Fukuyama, Seiichi, Yoshimoto, Kentaro, Shimokawa, Mototsugu, Saito, Akiko M., Ito, Suminobu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603008/
https://www.ncbi.nlm.nih.gov/pubmed/28915900
http://dx.doi.org/10.1186/s13063-017-2103-4
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author Saka, Hideo
Kitagawa, Chiyoe
Ichinose, Yukito
Takenoyama, Mitsuhiro
Ibata, Hidenori
Kato, Tatsuo
Takami, Koji
Yamashita, Motohiro
Maeda, Tadashi
Takeo, Sadanori
Ueda, Hitoshi
Okabayashi, Kan
Nagashima, Seiji
Oka, Tadayuki
Kouso, Hidenori
Fukuyama, Seiichi
Yoshimoto, Kentaro
Shimokawa, Mototsugu
Saito, Akiko M.
Ito, Suminobu
author_facet Saka, Hideo
Kitagawa, Chiyoe
Ichinose, Yukito
Takenoyama, Mitsuhiro
Ibata, Hidenori
Kato, Tatsuo
Takami, Koji
Yamashita, Motohiro
Maeda, Tadashi
Takeo, Sadanori
Ueda, Hitoshi
Okabayashi, Kan
Nagashima, Seiji
Oka, Tadayuki
Kouso, Hidenori
Fukuyama, Seiichi
Yoshimoto, Kentaro
Shimokawa, Mototsugu
Saito, Akiko M.
Ito, Suminobu
author_sort Saka, Hideo
collection PubMed
description BACKGROUND: As 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). METHODS: Subsequent 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 REGISTRATION: UMIN000010386 (R000012145). Registered on 1 April 2013. UMIN-CTR is officially recognized as a registration site which satisfies ICMJE criteria. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2103-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-56030082017-09-20 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 Saka, Hideo Kitagawa, Chiyoe Ichinose, Yukito Takenoyama, Mitsuhiro Ibata, Hidenori Kato, Tatsuo Takami, Koji Yamashita, Motohiro Maeda, Tadashi Takeo, Sadanori Ueda, Hitoshi Okabayashi, Kan Nagashima, Seiji Oka, Tadayuki Kouso, Hidenori Fukuyama, Seiichi Yoshimoto, Kentaro Shimokawa, Mototsugu Saito, Akiko M. Ito, Suminobu Trials Study Protocol BACKGROUND: As 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). METHODS: Subsequent 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 REGISTRATION: UMIN000010386 (R000012145). Registered on 1 April 2013. UMIN-CTR is officially recognized as a registration site which satisfies ICMJE criteria. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2103-4) contains supplementary material, which is available to authorized users. BioMed Central 2017-09-15 /pmc/articles/PMC5603008/ /pubmed/28915900 http://dx.doi.org/10.1186/s13063-017-2103-4 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Saka, Hideo
Kitagawa, Chiyoe
Ichinose, Yukito
Takenoyama, Mitsuhiro
Ibata, Hidenori
Kato, Tatsuo
Takami, Koji
Yamashita, Motohiro
Maeda, Tadashi
Takeo, Sadanori
Ueda, Hitoshi
Okabayashi, Kan
Nagashima, Seiji
Oka, Tadayuki
Kouso, Hidenori
Fukuyama, Seiichi
Yoshimoto, Kentaro
Shimokawa, Mototsugu
Saito, Akiko M.
Ito, Suminobu
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603008/
https://www.ncbi.nlm.nih.gov/pubmed/28915900
http://dx.doi.org/10.1186/s13063-017-2103-4
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