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国立がん研究センター 中央病院

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Clinical Research Support office

Yasuhiro Fujiwara

Clinical Trial Coordination (& Support) Office

Noboru Yamamoto, Hiroko Nakahama, Noriko Kobayashi, Miki Ito, Kikue Kamiyama, Harue Ui, Shino Ohsawa, Tamami Yamano, Suga Yamagami, Chie Miyano, Yuko Tagami, Yukari Nishiyama, Saki Yoshizawa, Ai Sekido, Akiko Saito, Asako Sakamoto, Kumiko Hirayama, Kiyoka Ishihama, Yukari Hoshina, Tomomi Tsuchiya, Katsuyuki Ikarashi, Mari Takahashi, Sho Murata, Yoshimi Yamaguchi, Keiko Wakakuwa, Yukiko Nishioka, Yumiko Ikuno, Mayumi Ikeda, Hiroko Minami, Kimiko Sega, Mai Koda, Haruka Sawamura, Harumi Mochizuki, Ami Hashimoto, Satomi Nakamori, Tsukina Soku

Clinical Trial Management Section

Kenichi Nakamura, Hiroshi Katayama, Tamie Sukigara, Ritsuko Nagasaka, Tomomi Hata, Mamiko Kawasaki, Satoshi Kawashima, Miho Sakai, Junko Eba, Keisuke Kanato, Kenichi Miyamoto, Hideaki Kitahara, Taro Shibata, Aya Kuchiba, Junki Mizusawa, Kan Yonemori, Natsuko Okita, Hideki Ueno

Data Management Section

Haruhiko Fukuda, Harumi Kaba, Yushi Nagai, Chika Asami, Nobuko Okamura, Ryuji Makiuchi, Futa Kikuhara, Miwa Kihara, Sakiko Fushimi, Kaoru Koike, Tamie Kawano

Office of Biobank and Translational Research

Ken Kato, Teiko Yamane, Suga, Yamagami, Keiko Wakakuwa, Mayumi Ikeda, Harumi Mochizuki, Satomi Nakamori, Tokiko Konuma

Introduction

In 2015, the Research Coordination Division and the Research Promotion Division of the Center for Research Administration and Support (CRAS), the Clinical Trial Coordination (& Support) Office and Biobank and the Translational Research Support section of the National Cancer Center Hospital (NCCH) were reorganized into the Clinical Research Support Division of the NCCH. The Clinical Research Support Office supports clinical research conducted under the leadership of investigators in the Hospital. Supporting activities include protocol writing, central/local data management, statistical design and analysis, in-house/on-site monitoring, audits, patient recruitment, and other coordinating jobs.

Activities and future prospects of each section

Clinical Trial Coordination (& Support) Office

The Clinical Trial Coordination (& Support) Office supports a lot of the industry-sponsored registration trials as well as the physician-initiated registration-directed clinical trials. A total of 28 CRCs (clinical research coordinators) are supporting these trials. The number of industry-sponsored registration trials is increasing year by year, and we supported 270 registration-directed clinical trials including 20 physician-initiated registrationdirected clinical trials in 2015 (Table 1). The number of supported clinical trials is increasing as previously described, and the supporting area covered by the CRCs will be expanded to include not only registration trials but also other investigator-initiated clinical trials. Therefore, the expansion of CRC staff members is highly anticipated. In view of the plan for the NCCH, all members of this Office will work together to contribute to reinforcing the clinical research capabilities of the NCCH and to making this Office a valuable unit for all members of our hospital.

Table 1. Supported Trials in Clinical Trial Coordination (& Support) Office in 2015

 

Clinical Trial Management Section

The Clinical Trial Management Section has five functions: i) Multi-institutional trial support, ii) Investigational new drug (IND) trial management, iii) Biostatistics, iv) Safety management, and v) Pharmaceutical affairs consultation. One of the strengths of the NCCH is implementing various types of clinical trials covering both early phase trials including first-in-human trials and late phase multi-institutional trials. The IND trial management function is responsible for comprehensive study coordination and site visit monitoring in early phase trials. The multi-institutional trial support function works as the JCOG Operations Office, which engages in protocol development, manuscript drafting, study coordination, etc., for late phase trials. The section is also responsible for coordination of the study planning consultation meeting and the concept review committee meeting. As a future direction, the section will reinforce the support function for various types of clinical trials including advanced medical care systems.

Data Management Section

The section is responsible for central data management and in-house study monitoring in the investigator-initiated clinical trials for cancer therapeutic development. The Section consists of 3 teams: (1) Data managers in JCOG Data Center, (2) In-house research team, (3) Pediatric research team. The JCOG Data Center mostly supports late development multi-modality multi-institutional phase II or phase III trials for adult cancer. The inhouse research team supports early phase adult cancer trials mainly for drug development including registration trials. The pediatric research team supports mainly registration trials for pediatric cancer.

The section is introducing a web-based electronic data capturing (EDC) system and is promoting standardization of all aspects of data management, such as data format, case report forms and monitoring reports for increasing data integrity and cost effectiveness of day-to-day work.

Biobank and Translational Research Support Section

The Biobank and Translational Research Support Section has routinely obtained informed consent to participate as an NCCBB donor from patients who consult with the NCCH for the first time. Clinical research coordinators in this section coordinate translational research in several ways, such as assistance of registration for clinical trials, logistics of pathological specimens, data collection for case report forms and coordination between sections.
We explained the purpose of NCCBB to 5,991 patients from May 2015 to January 2016, and received consent for blood collection and research use of their surplus samples for research from 5,371 patients (89.7% consent rate). The patient load with our assistance in filling in the preliminary-diagnosis card and so on was 6,337.
We support 6 biomarker trials, and for registered patients (pts), 62 pts for BT-SCRUM, 74 pts for TOP-GEAR study, 14 pts for liver amino acid trial, 45 pts for GI-SCREEN_CRC, 42 pts for GISCREEN_ nonCRC and 16 pts for DEF trial.

List of papers published in 2015

Journal

  1. Kataoka K, Aoyama I, Mizusawa J, Eba J, Minashi K, Yano T, Tanaka M, Hanaoka N, Katayama H, Takizawa K, Fukuda H, Muto M, Gastrointestinal Endoscopy Study Group (GIESG) of the Japan Clinical Oncology Group. A randomized controlled Phase II/III study comparing endoscopic balloon dilation combined with steroid injection versus radial incision and cutting combined with steroid injection for refractory anastomotic stricture after esophagectomy: Japan Clinical Oncology Group Study JCOG1207. Jpn J Clin Oncol, 45:385-389, 2015
  2. Kurokawa Y, Sasako M, Sano T, Yoshikawa T, Iwasaki Y, Nashimoto A, Ito S, Kurita A, Mizusawa J, Nakamura K, Japan Clinical Oncology Group (JCOG9502). Ten-year follow-up results of a randomized clinical trial comparing left thoracoabdominal and abdominal transhiatal approaches to total gastrectomy for adenocarcinoma of the oesophagogastric junction or gastric cardia. Br J Surg, 102:341-348, 2015
  3. Tahara M, Kiyota N, Mizusawa J, Nakamura K, Hayashi R, Akimoto T, Hasegawa Y, Iwae S, Monden N, Matsuura K, Fujii H, Onozawa Y, Homma A, Kubota A, Fukuda H, Fujii M. Phase II trial of chemoradiotherapy with S-1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706). Cancer Sci, 106:726-733, 2015
  4. Kato T, Takashima A, Kasamatsu T, Nakamura K, Mizusawa J, Nakanishi T, Takeshima N, Kamiura S, Onda T, Sumi T, Takano M, Nakai H, Saito T, Fujiwara K, Yokoyama M, Itamochi H, Takehara K, Yokota H, Mizunoe T, Takeda S, Sonoda K, Shiozawa T, Kawabata T, Honma S, Fukuda H, Yaegashi N, Yoshikawa H, Konishi I, Kamura T, Gynecologic Oncology Study Group of the Japan Clinical Oncology Group. Clinical tumor diameter and prognosis of patients with FIGO stage IB1 cervical cancer (JCOG0806-A). Gynecol Oncol, 137:34-39, 2015
  5. Satoh T, Tsuda H, Kanato K, Nakamura K, Shibata T, Takano M, Baba T, Ishikawa M, Ushijima K, Yaegashi N, Yoshikawa H, Gynecologic Cancer Study Group of the Japan Clinical Oncology Group. A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203). Jpn J Clin Oncol, 45:595-599, 2015
  6. Suzuki K, Watanabe S, Mizusawa J, Moriya Y, Yoshino I, Tsuboi M, Mizutani T, Nakamura K, Tada H, Asamura H, Japan Lung Cancer Surgical Study Group (JCOG LCSSG). Predictors of non-neoplastic lesions in lung tumours showing groundglass opacity on thin-section computed tomography based on a multi-institutional prospective study†. Interact Cardiovasc Thorac Surg, 21:218-223, 2015
  7. Etoh T, Inomata M, Watanabe M, Konishi F, Kawamura Y, Ueda Y, Toujigamori M, Shiroshita H, Katayama H, Kitano S. Success rate of informed consent acquisition and factors influencing participation in a multicenter randomized controlled trial of laparoscopic versus open surgery for stage II/III colon cancer in Japan (JCOG0404). Asian J Endosc Surg, 8:419-423, 2015
  8. Hojo T, Masuda N, Mizutani T, Shibata T, Kinoshita T, Tamura K, Hara F, Fujisawa T, Inoue K, Saji S, Nakamura K, Fukuda H, Iwata H. Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204. Jpn J Clin Oncol, 45:983-986, 2015
  9. Homma A, Nakamura K, Matsuura K, Mizusawa J, Onimaru R, Fukuda H, Fujii M. Dose-finding and efficacy confirmation trial of superselective intra-arterial infusion of cisplatin and concomitant radiotherapy for patients with locally advanced maxillary sinus cancer (JCOG1212, RADPLAT-MSC). Jpn J Clin Oncol, 45:119-122, 2015
  10. Eba J, Shimokawa T, Nakamura K, Shibata T, Misumi Y, Okamoto H, Yamamoto N, Ohe Y, Lung Cancer Study Group of the Japan Clinical Oncology Group. A Phase II/III study comparing carboplatin and irinotecan with carboplatin and etoposide for the treatment of elderly patients with extensive-disease smallcell lung cancer (JCOG1201). Jpn J Clin Oncol, 45:115-118, 2015
  11. Matsumoto K, Katsumata N, Shibata T, Satoh T, Saitou M, Yunokawa M, Takano T, Nakamura K, Kamura T, Konishi I. Phase II trial of oral etoposide plus intravenous irinotecan in patients with platinum-resistant and taxane-pretreated ovarian cancer (JCOG0503). Gynecol Oncol, 136:218-223, 2015
  12. Nozaki I, Kato K, Igaki H, Ito Y, Daiko H, Yano M, Udagawa H, Mizusawa J, Katayama H, Nakamura K, Kitagawa Y. Evaluation of safety profile of thoracoscopic esophagectomy for T1bN0M0 cancer using data from JCOG0502: a prospective multicenter study. Surg Endosc, 29:3519-3526, 2015
  13. Yokota T, Ando N, Igaki H, Shinoda M, Kato K, Mizusawa J, Katayama H, Nakamura K, Fukuda H, Kitagawa Y. Prognostic Factors in Patients Receiving Neoadjuvant 5-Fluorouracil plus Cisplatin for Advanced Esophageal Cancer (JCOG9907). Oncology, 89:143-151, 2015
  14. Shinoda M, Ando N, Kato K, Ishikura S, Kato H, Tsubosa Y, Minashi K, Okabe H, Kimura Y, Kawano T, Kosugi S, Toh Y, Nakamura K, Fukuda H, Japan Clinical Oncology Group. Randomized study of low-dose versus standard-dose chemoradiotherapy for unresectable esophageal squamous cell carcinoma (JCOG0303). Cancer Sci, 106:407-412, 2015
  15. Kataoka K, Nakamura K, Mizusawa J, Fukuda H, Igaki H, Ozawa S, Hayashi K, Kato K, Kitagawa Y, Ando N. Variations in survival and perioperative complications between hospitals based on data from two phase III clinical trials for oesophageal cancer. Br J Surg, 102:1088-1096, 2015
  16. Tahara M, Fuse N, Mizusawa J, Sato A, Nihei K, Kanato K, Kato K, Yamazaki K, Muro K, Takaishi H, Boku N, Ohtsu A. Phase I/II trial of chemoradiotherapy with concurrent S-1 and cisplatin for clinical stage II/III esophageal carcinoma (JCOG 0604). Cancer Sci, 106:1414-1420, 2015
  17. Kataoka K, Tokunaga M, Mizusawa J, Machida N, Katayama H, Shitara K, Tomita T, Nakamura K, Boku N, Sano T, Terashima M, Sasako M, Stomach Cancer Study Group/Japan Clinical Oncology Group. A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study). Jpn J Clin Oncol, 45:1082-1086, 2015
  18. Nakamura K, Kuwata T, Shimoda T, Mizusawa J, Katayama H, Kushima R, Taniguchi H, Sano T, Sasako M, Fukuda H. Determination of the optimal cutoff percentage of residual tumors to define the pathological response rate for gastric cancer treated with preoperative therapy (JCOG1004-A). Gastric Cancer, 18:597-604, 2015
  19. Mizutani T, Tanaka M, Eba J, Mizusawa J, Fukuda H, Hanaoka N, Takeuchi M, Aoyama I, Kojima T, Takizawa K, Ono H, Muto M, Gastrointestinal Endoscopy Study Group of the Japan Clinical Oncology Group (JCOG). A Phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection (JCOG1217, Steroid EESD P3). Jpn J Clin Oncol, 45:1087-1090, 2015