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
Abstract 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 o...
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BMC
2017-09-01
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Online Access: | http://link.springer.com/article/10.1186/s13063-017-2103-4 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Hideo Saka Chiyoe Kitagawa Yukito Ichinose Mitsuhiro Takenoyama Hidenori Ibata Tatsuo Kato Koji Takami Motohiro Yamashita Tadashi Maeda Sadanori Takeo Hitoshi Ueda Kan Okabayashi Seiji Nagashima Tadayuki Oka Hidenori Kouso Seiichi Fukuyama Kentaro Yoshimoto Mototsugu Shimokawa Akiko M. Saito Suminobu Ito |
spellingShingle |
Hideo Saka Chiyoe Kitagawa Yukito Ichinose Mitsuhiro Takenoyama Hidenori Ibata Tatsuo Kato Koji Takami Motohiro Yamashita Tadashi Maeda Sadanori Takeo Hitoshi Ueda Kan Okabayashi Seiji Nagashima Tadayuki Oka Hidenori Kouso Seiichi Fukuyama Kentaro Yoshimoto Mototsugu Shimokawa Akiko M. Saito Suminobu Ito 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 Trials Non-small cell lung cancer Immunotherapy Phase II |
author_facet |
Hideo Saka Chiyoe Kitagawa Yukito Ichinose Mitsuhiro Takenoyama Hidenori Ibata Tatsuo Kato Koji Takami Motohiro Yamashita Tadashi Maeda Sadanori Takeo Hitoshi Ueda Kan Okabayashi Seiji Nagashima Tadayuki Oka Hidenori Kouso Seiichi Fukuyama Kentaro Yoshimoto Mototsugu Shimokawa Akiko M. Saito Suminobu Ito |
author_sort |
Hideo Saka |
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_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_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_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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2017-09-01 |
description |
Abstract 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. |
topic |
Non-small cell lung cancer Immunotherapy Phase II |
url |
http://link.springer.com/article/10.1186/s13063-017-2103-4 |
work_keys_str_mv |
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doaj-478109fb6b444fdb99397dbffb2a11cf2020-11-25T00:37:12ZengBMCTrials1745-62152017-09-011811710.1186/s13063-017-2103-4A 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 trialHideo Saka0Chiyoe Kitagawa1Yukito Ichinose2Mitsuhiro Takenoyama3Hidenori Ibata4Tatsuo Kato5Koji Takami6Motohiro Yamashita7Tadashi Maeda8Sadanori Takeo9Hitoshi Ueda10Kan Okabayashi11Seiji Nagashima12Tadayuki Oka13Hidenori Kouso14Seiichi Fukuyama15Kentaro Yoshimoto16Mototsugu Shimokawa17Akiko M. Saito18Suminobu Ito19Department of Respiratory Medicine, National Hospital Organization Nagoya Medical CenterDepartment of Respiratory Medicine, National Hospital Organization Nagoya Medical CenterDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer CenterDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer CenterDepartment of Respiratory Medicine, National Hospital Organization Mie Chuo Medical CenterDepartment of Respiratory Medicine, National Hospital Organization Nagara Medical CenterDepartment of Respiratory Medicine, National Hospital Organization Osaka Medical CenterDepartment of Thoracic Surgery, National Hospital Organization Shikoku Cancer CenterDepartment of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical CenterDepartment of Thoracic Surgery, National Hospital Organization Kyushu Medical CenterDepartment of Surgery, National Hospital Organization Fukuoka HospitalDepartment of Thoracic Surgery, National Hospital Organization Fukuoka Higashi Medical CenterDepartment of Respiratory Medicine, National Hospital Organization Nagasaki Medical CenterDepartment of Surgery, National Hospital Organization Ureshino Medical CenterDepartment of Thoracic Surgery, National Hospital Organization Oita Medical CenterDepartment of Thoracic Surgery, National Hospital Organization Beppu Medical CenterDepartment of Thoracic Surgery, National Hospital Organization Minami Kyushu National HospitalClinical Research Center, National Hospital Organization Kyushu Cancer CenterClinical Research Center, National Hospital Organization Nagoya Medical CenterClinical Research Center, National Hospital OrganizationAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2103-4Non-small cell lung cancerImmunotherapyPhase II |