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,
Hitoshi Ueda,
Kan Okabayashi,
Seiji Nagashima,
Tadayuki Oka,
Hidenori Kouso,
Seiichi Fukuyama,
Kentaro Yoshimoto,
Mototsugu Shimokawa,
Akiko M. Saito,
Suminobu Ito
Affiliations
Hideo Saka
Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center
Chiyoe Kitagawa
Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center
Yukito Ichinose
Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center
Mitsuhiro Takenoyama
Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center
Hidenori Ibata
Department of Respiratory Medicine, National Hospital Organization Mie Chuo Medical Center
Tatsuo Kato
Department of Respiratory Medicine, National Hospital Organization Nagara Medical Center
Koji Takami
Department of Respiratory Medicine, National Hospital Organization Osaka Medical Center
Motohiro Yamashita
Department of Thoracic Surgery, National Hospital Organization Shikoku Cancer Center
Tadashi Maeda
Department of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center
Sadanori Takeo
Department of Thoracic Surgery, National Hospital Organization Kyushu Medical Center
Hitoshi Ueda
Department of Surgery, National Hospital Organization Fukuoka Hospital
Kan Okabayashi
Department of Thoracic Surgery, National Hospital Organization Fukuoka Higashi Medical Center
Seiji Nagashima
Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center
Tadayuki Oka
Department of Surgery, National Hospital Organization Ureshino Medical Center
Hidenori Kouso
Department of Thoracic Surgery, National Hospital Organization Oita Medical Center
Seiichi Fukuyama
Department of Thoracic Surgery, National Hospital Organization Beppu Medical Center
Kentaro Yoshimoto
Department of Thoracic Surgery, National Hospital Organization Minami Kyushu National Hospital
Mototsugu Shimokawa
Clinical Research Center, National Hospital Organization Kyushu Cancer Center
Akiko M. Saito
Clinical Research Center, National Hospital Organization Nagoya Medical Center
Suminobu Ito
Clinical Research Center, National Hospital Organization
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.
