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Annual Report 2021

Department of Clinical Research Support

  • Clinical Research Coordinating Division
    Hideki Ueno, Chie Miyano, Kikue Hasegawa, Asako Sakamoto, Emi Yasuda, Sho Murata, Mari Takahashi, Hiroko Kawaguchi, Shinobu Araki, Chiharu Nakano, Asako Kamikawa, Setsuko Kamizaki, Yoshimi Yamaguchi, Yumiko Ikuno, Kimiyo Yoshii, Hiroko Takagi, Maki Takayasu, Aya Matsumoto, Yukako Takasaki, Ran Obara, Harue Ui, Tamami Yamano, Kayo Mukai, Nahoko Hiraoka, Tomomi Tsuchiya, Hatsuki Ohno, Noriko Makita, Chikano Yashiro, Eri Yanagisawa, Yukari Nishiyama, Azumi Seko, Ai Sekido, Rie Goto, Tomoko Morita, Marie Komagata, Miki Shiraiwa, Aya Shiroichi, Anna Yashima, Miki Tamaki, Saki Yoshizawa, Satsuki Otani, Ritsuko Yamamoto, Kazumi Higuchi, Ai Kobayakawa, Maya Niigawa, Hiroe Takayama, Mari Kondo, Tomoko Jinbo, Shiho Isobe, Junko Kojima, Chie Motegi, Kimiko Sega, Katsuaki Imaizumi, Nobuko Ushirozawa, Yoshiko Kanazu, Yoko Ebihara, Harumi Maruno, Junko Horie, Eiko Mimata, Kaori Matsushita, Yuriko Shinotsuka, Yuki Sezaki, Satoko Murakami, Chiaki Yamamoto, Ken Kato, Teiko Yamane, Keiko Wakakuwa, Keiko Shimo, Mayumi Ikeda, Satomi Nakamori, Harumi Mochizuki, Riko Tamura, Sayaka Oba, Azusa Komada
  • Research Management Division
    Kenichi Nakamura, Natsuko Okita, Tomomi Hata, Tetsuya Sasaki, Makiko Watanabe, Takako Hitomi, Mitsumi Terada, Hisahiro Ito, Naoko Matsui, Mamiko Kawasaki, Hitomi Okuma, Satoshi Kawashima, Masahiko Ichimura, Chiharu Mizoguchi, Yayoi Ando, Hitoshi Ozawa, Naoko So, Masako Inaba, Reiko Isomura, Mamiko Nakata, Eri Tsutui, Sawako Tomatsuri, Sachie Kawabata, Eiko Yorikane, Yoshie Shuda, Kenta Anjo, Kaori Izumino, Satoshi Azuma, Kazumi Ono, Junko Eba, Tomoko Kataoka, Keisuke Kanato, Keita Sasaki, Yuta Sekino, Yusuke Sano, Hideki Masai, Kaori Umegai, Junki Mizusawa, Gakuto Ogawa, Ryunosuke Machida, Shun Sadachi, Taro Shibata, Aya Kuchiba, Shogo Nomura, Akihiro Hirakawa, Kohei Uemura, Ryo Kitabayashi, Naomi Konishi, Masashi Mikami, Shintaro Iwamoto, Chihiro Yaita, Yuki Konda
  • Data Management Division
    Haruhiko Fukuda, Harumi Kaba, Hiromi Katsuki, Keiko Hoyano, Yayoi Mitsumori, Tomoko Kojima, Mikio Mori, Nobuko Okamura, Ryuji Makiuchi, Keiko Ohata, Yukari Hoshina, Masahisa Kamikura, Yukari Nagasaka, Eiko Sayama, Eru Adachi, Kazumi Kurishita, Yuki Kazumi, Ako, Toyoda, Kayo Sawaki, Keiko Suto

Introduction

 The Clinical Research Support Office supports clinical research conducted under the leadership of investigators in the National Cancer Center Hospital (NCCH). Support activities include protocol writing, central/local data management, statistical design and analysis, in-house/on-site monitoring, audits, patient recruitment, and other coordinating jobs.

The Team and What We Do

  • Clinical Research Coordinating Division

 The Clinical Research Coordinating Section and the Clinical Trial Administration Section support a lot of industry-sponsored registration-directed trials as well as investigator-initiated registration-directed trials.

 The Biobank and Translational Research Support Section has routinely obtained informed consent to participate as an NCC biobank (NCCBB) donor from patients who consult with the NCCH for the first time. CRCs in this section coordinate translational research in several ways, such as assistance for registration for clinical trials, logistics for pathological specimens, data collection for case report forms, and coordination between sections.

  • Research Management Division

 The Research Management Division is in charge of central research support functions: i) International clinical trial management, ii) Investigator-initiated registration-directed trial (Chiken) management, iii) Monitoring & consultation, iv) Multi-institutional clinical trial support, v) Biostatistics, vi) Pharmaceutical affairs consultation. The division has the capability to support various types of clinical trials covering both early phase ones including first-in-human trials and late phase multi-institutional trials. For the early phase trials, the division mainly offers comprehensive study management, site visit monitoring and safety information management. One of the strengths of the division is that it can coordinate not only domestic trials but also international investigator-initiated registration-directed trials. The multi-institutional trial support function works as the Japan Clinical Oncology Group (JCOG) Operations Office which engages in protocol development, manuscript drafting, study coordination, etc. for late phase trials.

  • Data Management Division

 The Data Management Division is responsible for central data management and in-house study monitoring in investigator-initiated clinical trials for cancer therapeutic development. The Data Management Section supports early phase cancer trials mainly for drug development including registration trials which are led by physicians in the NCCH. The Multi-institutional Data Management Section supports mostly late development multi-modality multi-institutional phase II or phase III trials for adult solid cancer conducted by the Japan Clinical Oncology Group (JCOG).

Clinical trials

  • Clinical Research Coordinating Division

 The number of registration-directed clinical trials is increasing year by year, and the division supported 507 registration-directed trials including 60 investigator-initiated registration-directed trials in FY 2021 (Table 1).

  • Research Management Division

 The priority area of the division is genomic medicine, rare cancer and international trials. As of the end of the fiscal year 2021, the Research Management Division supported 21 investigator-initiated registration-directed trials, 13 clinical trials using the Advanced Medical Care system and two trials under patient-proposed health services. This division has been in charge of the coordinating office of rare cancer registry study with basket sub-studies (MASTER KEY Project). This division also supports an international investigator-initiated registration-directed trial (PATHWAY trial).

  • Data Management Division

 The Data Management Section supports 17 IND trials (5 open, 3 in preparation, 9 on follow-up) and 9 non-IND studies (7 open, 1 in preparation, 1 on follow-up). The Multi-institutional Data Management Section supports 101 non-IND trials (48 open, 14 in preparation, 39 on follow-up) as the JCOG Data Center.

Table 1. Supported Trials in the Clinical Research Coordinating Division in FY 2021
Table 1. Supported Trials in the Clinical Research Coordinating Division in FY 2021

Table 1. Supported Trials in the Clinical Research Coordinating Division in FY 2021
Table 1. Supported Trials in the Clinical Research Coordinating Division in FY 2021

Education

  • Clinical Research Coordinating Division

 The staff members received not only day-to-day on-the-job training but also in-house educational seminars in order to learn how to support clinical trials including investigator-initiated registration-directed trials.

  • Research Management Division

 The staff members received not only day-to-day on-the-job training but also various seminars related to clinical trials held within the National Cancer Center or scientific meetings in order to learn how to support clinical trials including investigator-initiated registration trials. Division

  • Data Management Division

    •  Data managers in the division are encouraged to attend the various seminars related to research ethics and clinical trials held within the National Cancer Center, in-house lectures organized by the Clinical Research Support Office, scientific meetings and seminars organized by the Japan Society of Clinical Trials and Research or the Ministry of Health, Labour and Welfare and so on. The division is also continuously promoting on-the-job training of data managers to teach them clinical trial methodology, data management and research ethics.

Future Prospects

  • Clinical Research Coordinating Division

 The number of supported clinical trials is increasing as previously described, and the supported area covered by CRCs will be expanded to include not only registration trials but also other investigator-initiated clinical trials. Therefore, 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 clinical research capabilities of the NCCH and to making this office a valuable unit for all members of our hospital.

 The members of the Biobank and Translational Research Support Section received seminars which are related to clinical research ethics, etc. The section informs and educates investigators of the NCC about the NCC biobank and translational research periodically through the NCC University. As a future direction, the section will improve the quality of the NCC bioban’s informatics and storage of serum. The section also aims to establish a support system for higher quality and quantity.

  • Research Management Division

 Since the number of investigator-initiated registration-directed trials has increased, reinforcement of staff resources is urgently needed. In response to this increase, this division will reinforce the support function for various clinical trials including international clinical trials, investigator-initiated registration-directed trials, Advanced Medical Care system trials, patient-proposed health services trials, and a new type of clinical trial (platform trials). Also, this division will establish optimal ways to cope with the Clinical Research Act and revised Ethical Guidelines.

  • Data Management Division

 The Data Management Division has introduced a web-based electronic data capturing (EDC) system and is promoting standardization of all aspects of data management, such as data formats, case report forms and monitoring reports for increased data integrity, and cost effectiveness of day-to-day work.

List of papers published in 2021

Journal

1. Hironaka S, Sadachi R, Machida N, Iwasa S, Yamada Y, Sasako M, Yoshikawa T, Boku N, Terashima M. Association of renal function with the safety and efficacy of cisplatin plus S-1 therapy and docetaxel plus cisplatin plus S-1 therapy in patients with advanced gastric cancer: an exploratory analysis of JCOG1013. Japanese journal of clinical oncology, 52:14-23, 2022

2. Nozaki I, Machida R, Kato K, Daiko H, Ito Y, Kojima T, Yano M, Ueno M, Nakagawa S, Kitagawa Y. Long-term survival of patients with T1bN0M0 esophageal cancer after thoracoscopic esophagectomy using data from JCOG0502: a prospective multicenter trial. Surgical endoscopy, 36:4275-4282, 2022

3. Misawa K, Kurokawa Y, Mizusawa J, Takiguchi S, Doki Y, Makino S, Choda Y, Takeno A, Tokunaga M, Sano T, Sasako M, Yoshikawa T, Terashima M. Negative impact of intraoperative blood loss on long-term outcome after curative gastrectomy for advanced gastric cancer: exploratory analysis of the JCOG1001 phase III trial. Gastric cancer: official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 25:459-467, 2022

4. Shiraishi Y, Hakozaki T, Nomura S, Kataoka T, Tanaka K, Miura S, Sekino Y, Ando M, Horinouchi H, Ohe Y, Okamoto I. A Multicenter, Randomized Phase III Study Comparing Platinum Combination Chemotherapy Plus Pembrolizumab With Platinum Combination Chemotherapy Plus Nivolumab and Ipilimumab for Treatment-Naive Advanced Non-Small Cell Lung Cancer Without Driver Gene Alterations: JCOG2007 (NIPPON Study). Clinical lung cancer, 23:e285-e288, 2022

5. Ohue M, Fujita S, Mizusawa J, Kanemitsu Y, Hamaguchi T, Tsukamoto S, Noura S, Yasui M, Itoh M, Shiomi A, Komori K, Watanabe J, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Moriya Y. Preoperative and postoperative prognostic factors of patients with stage II/III lower rectal cancer without neoadjuvant therapy in the clinical trial (JCOG0212). Japanese journal of clinical oncology, 52:114-121, 2022

6. Yoshida M, Takizawa K, Hasuike N, Ono H, Boku N, Kadota T, Mizusawa J, Oda I, Yoshida N, Horiuchi Y, Hirasawa K, Morita Y, Yamamoto Y, Muto M. Second gastric cancer after curative endoscopic resection of differentiated-type early gastric cancer: post-hoc analysis of a single-arm confirmatory trial. Gastrointestinal endoscopy, 95:650-659, 2022

7. Oshima K, Kato K, Ito Y, Daiko H, Nozaki I, Nakagawa S, Shibuya Y, Kojima T, Toh Y, Okada M, Hironaka S, Akiyama Y, Komatsu Y, Maejima K, Nakagawa H, Onuki R, Nagai M, Kato M, Kanato K, Kuchiba A, Nakamura K, Kitagawa Y. Prognostic biomarker study in patients with clinical stage I esophageal squamous cell carcinoma: JCOG0502-A1. Cancer science, 113:1018-1027, 2022

8. Aokage K, Tsuboi M, Zenke Y, Horinouchi H, Nakamura N, Ishikura S, Nishikawa H, Kumagai S, Koyama S, Kanato K, Kataoka T, Wakabayashi M, Fukutani M, Fukuda H, Ohe Y, Watanabe SI. Study protocol for JCOG1807C (DEEP OCEAN): a interventional prospective trial to evaluate the efficacy and safety of durvalumab before and after operation or durvalumab as maintenance therapy after chemoradiotherapy against superior sulcus non-small cell lung cancer. Japanese journal of clinical oncology, 52:383-387, 2022

9. Yamada I, Morizane C, Okusaka T, Mizusawa J, Kataoka T, Ueno M, Ikeda M, Okano N, Todaka A, Shimizu S, Mizuno N, Sekimoto M, Tobimatsu K, Yamaguchi H, Nishina T, Shirakawa H, Kojima Y, Oono T, Kawamoto Y, Furukawa M, Iwai T, Sudo K, Okamura K, Yamashita T, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. The clinical outcomes of combination chemotherapy in elderly patients with advanced biliary tract cancer: an exploratory analysis of JCOG1113. Scientific reports, 12:987, 2022

10. Oda Y, Tanaka K, Hirose T, Hasegawa T, Hiruta N, Hisaoka M, Yoshimoto M, Otsuka H, Bekki H, Ishii T, Endo M, Kunisada T, Hiruma T, Tsuchiya H, Katagiri H, Matsumoto Y, Kawai A, Nakayama R, Kawashima H, Takenaka S, Emori M, Watanuki M, Yoshida Y, Okamoto T, Mizusawa J, Fukuda H, Ozaki T, Iwamoto Y, Nojima T. Standardization of evaluation method and prognostic significance of histological response to preoperative chemotherapy in high-grade non-round cell soft tissue sarcomas. BMC cancer, 22:94, 2022

11. Terashima M, Sano T, Mizusawa J, Umemura K, Tokunaga M, Omori T, Cho H, Hasegawa Y, Akiyama Y, Tsujimoto H, Kawashima Y, Kawachi Y, Lee SW, Kano K, Hasegawa H, Boku N, Yoshikawa T, Sasako M. Prediction of the peritoneal recurrence via the macroscopic diagnosis of the serosal invasion in patients with gastric cancer: Supplementary analysis of JCOG0110. European journal of surgical oncology: the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology, 2022

12. Takii Y, Mizusawa J, Kanemitsu Y, Komori K, Shiozawa M, Ohue M, Ikeda S, Takiguchi N, Kobatake T, Ike H, Sato T, Tomita N, Ota M, Masaki T, Hamaguchi T, Shida D, Katayama H, Shimada Y, Fukuda H. The Conventional Technique Versus the No-touch Isolation Technique for Primary Tumor Resection in Patients With Colon Cancer (JCOG1006): A Multicenter, Open-label, Randomized, Phase III Trial. Annals of surgery, 275:849-855, 2022

13. Horiuchi Y, Takizawa K, Yoshio T, Mizusawa J, Ono H, Hasuike N, Yano T, Yoshida N, Miwa H, Boku N, Terashima M, Muto M. Pretreatment risk factors for endoscopic noncurative resection of gastric cancers with undifferentiated-type components. Journal of gastroenterology and hepatology, 37:758-765, 2022

14. Yoshio T, Minashi K, Mizusawa J, Morita Y, Tajika M, Fujiwara J, Yamamoto Y, Katada C, Hori S, Yano T, Takizawa K, Fukuda H, Muto M. Effect of chemoradiation on the development of second primary cancers after endoscopic resection of T1 esophageal squamous cell carcinoma. Esophagus: official journal of the Japan Esophageal Society, 19:469-476, 2022

15. Kobayashi T, Yamamoto K, Kagami Y, Machida R, Miyazaki K, Nakamura S, Kuroda J, Maruyama D, Nagai H. Prognostic value of the Kyoto Prognostic Index in higher-risk diffuse large B-cell lymphomas treated by upfront autologous stem cell transplantation in JCOG0908 trial. Japanese journal of clinical oncology, 52:583-588, 2022

16. Kiyota N, Tahara M, Mizusawa J, Kodaira T, Fujii H, Yamazaki T, Mitani H, Iwae S, Fujimoto Y, Onozawa Y, Hanai N, Ogawa T, Hara H, Monden N, Shimura E, Minami S, Fujii T, Tanaka K, Homma A, Yoshimoto S, Oridate N, Omori K, Ueda T, Okami K, Ota I, Shiga K, Sugasawa M, Asakage T, Saito Y, Murono S, Nishimura Y, Nakamura K, Hayashi R. Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, JCO2101293, 2022

17. Nakamura K, Ozawa H, Shibata T, Ushirozawa N, Hata T, Okita N, Fuse N, Sato N, Ikeda K, Hanaoka H, Maruyama T, Wada M, Shimizu S, Kasai H, Yamamoto Y, Sakurai J, Todaka K, Tashiro S, Yamamoto H. Survey Results and Recommendations from Japanese Stakeholders for Good Clinical Practice Renovation. Therapeutic innovation & regulatory science, 56:220-229, 2022

18. Suzuki K, Watanabe SI, Wakabayashi M, Saji H, Aokage K, Moriya Y, Yoshino I, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H. A single-arm study of sublobar resection for ground-glass opacity dominant peripheral lung cancer. The Journal of thoracic and cardiovascular surgery, 163:289-301.e2, 2022

19. Nakamura N, Maruyama D, Machida R, Ichinohe T, Takayama N, Ohba R, Ohmachi K, Imaizumi Y, Tokunaga M, Katsuya H, Yoshida I, Sunami K, Kurosawa M, Kubota N, Morimoto H, Kobayashi M, Kato H, Kameoka Y, Kagami Y, Kizaki M, Takeuchi K, Munakata W, Iida S, Nagai H. Single response assessment of transplant-ineligible multiple myeloma: a supplementary analysis of JCOG1105 (JCOG1105S1). Japanese journal of clinical oncology, 51:1059-1066, 2021

20. Ishikawa M, Shibata T, Iwata T, Nishio S, Takada T, Suzuki S, Horie K, Kudaka W, Kagabu M, Tanikawa M, Kitagawa R, Takekuma M, Kobayashi H, Yaegashi N. A randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab versus dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent, or persistent cervical carcinoma (JCOG1311): Primary analysis. Gynecologic oncology, 162:292-298, 2021

21. Miyoshi T, Aokage K, Wakabayashi M, Shimoyama R, Kataoka T, Fukuda H, Watanabe SI. Prospective evaluation of watchful waiting for early-stage lung cancer with ground-glass opacity: a single-arm confirmatory multicenter study: Japan Clinical Oncology Group study JCOG1906 (EVERGREEN study). Japanese journal of clinical oncology, 51:1330-1333, 2021

22. Ueno M, Morizane C, Okusaka T, Mizusawa J, Kataoka T, Ikeda M, Ozaka M, Okano N, Sugimori K, Todaka A, Shimizu S, Mizuno N, Yamamoto T, Sano K, Tobimatsu K, Katanuma A, Miyamoto A, Yamaguchi H, Nishina T, Shirakawa H, Kojima Y, Oono T, Kawamoto Y, Furukawa M, Iwai T, Sudo K, Miyakawa H, Yamashita T, Yasuda I, Takahashi H, Kato N, Shioji K, Shimizu K, Nakagohri T, Kamata K, Ishii H, Furuse J. Comparison of gemcitabine-based chemotherapies for advanced biliary tract cancers by renal function: an exploratory analysis of JCOG1113. Scientific reports, 11:12885, 2021

23. Shimomura A, Tamura K, Tanaka K, Mizutani T, Sasaki K, Sekino Y, Sawaki M, Shien T, Shibata T, Iwata H. A randomized phase III study comparing trastuzumab emtansine with trastuzumab, pertuzumab and docetaxel in elderly patients with advanced stage HER2-positive breast cancer: Japan Clinical Oncology Group Study (JCOG1607, HERB TEA study). Japanese journal of clinical oncology, 51:1471-1474, 2021

24. Matsuo Y, Nagata Y, Wakabayashi M, Ishikura S, Onishi H, Kokubo M, Karasawa K, Shioyama Y, Onimaru R, Hiraoka M. Impact of pre-treatment C-reactive protein level and skeletal muscle mass on outcomes after stereotactic body radiotherapy for T1N0M0 non-small cell lung cancer: a supplementary analysis of the Japan Clinical Oncology Group study JCOG0403. Journal of radiation research, 62:901-909, 2021

25. Katsumata K, Enomoto M, Ishizaki T, Fujita S, Kanemitsu Y, Ito M, Shiomi A, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bando H, Sekimoto M, Kobatake T, Machida R, Akasu T, Moriya Y. Risk factors for surgical site infection and association of surgical site infection with survival of lower rectal cancer patients without clinical lateral pelvic lymph node metastasis (clinical Stage II/III): Analysis of data from JCOG0212. Clinical & experimental metastasis, 38:459-466, 2021

26. Kanemitsu Y, Shimizu Y, Mizusawa J, Inaba Y, Hamaguchi T, Shida D, Ohue M, Komori K, Shiomi A, Shiozawa M, Watanabe J, Suto T, Kinugasa Y, Takii Y, Bando H, Kobatake T, Inomata M, Shimada Y, Katayama H, Fukuda H. Hepatectomy Followed by mFOLFOX6 Versus Hepatectomy Alone for Liver-Only Metastatic Colorectal Cancer (JCOG0603): A Phase II or III Randomized Controlled Trial. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, 39:3789-3799, 2021

27. Ishihara R, Mizusawa J, Kushima R, Matsuura N, Yano T, Kataoka T, Fukuda H, Hanaoka N, Yoshio T, Abe S, Yamamoto Y, Nagata S, Ono H, Tamaoki M, Yoshida N, Takizawa K, Muto M. Assessment of the Diagnostic Performance of Endoscopic Ultrasonography After Conventional Endoscopy for the Evaluation of Esophageal Squamous Cell Carcinoma Invasion Depth. JAMA network open, 4:e2125317, 2021

28. Kobayashi S, Ueno M, Ogawa G, Fukutomi A, Ikeda M, Okusaka T, Sato T, Ito Y, Kadota T, Ioka T, Sugimori K, Sata N, Nakamori S, Shimizu K, Mizuno N, Ishii H, Furuse J. Impact of Renal Function on S-1 + Radiotherapy for Locally Advanced Pancreatic Cancer: An Integrated Analysis of Data From 2 Clinical Trials. Pancreas, 50:965-971, 2021

29. Arakawa Y, Sasaki K, Mineharu Y, Uto M, Mizowaki T, Mizusawa J, Sekino Y, Ono T, Aoyama H, Satomi K, Ichimura K, Kinoshita M, Ohno M, Ito Y, Nishikawa R, Fukuda H, Nishimura Y, Narita Y. A randomized phase III study of short-course radiotherapy combined with Temozolomide in elderly patients with newly diagnosed glioblastoma; Japan clinical oncology group study JCOG1910 (AgedGlio-PIII). BMC cancer, 21:1105, 2021

30. Katayama H, Inomata M, Mizusawa J, Nakamura K, Watanabe M, Akagi T, Yamamoto S, Ito M, Kinugasa Y, Okajima M, Takemasa I, Okuda J, Shida D, Kanemitsu Y, Kitano S. Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404). Annals of gastroenterological surgery, 5:823-831, 2021

31. Saito S, Akagi T, Katayama H, Wakabayashi M, Inomata M, Yamamoto S, Ito M, Kinugasa Y, Egi H, Munakata Y, Kokuba Y, Bando H, Yasui M, Ikeda M, Nakajima K, Shida D, Kanemitsu Y, Kitano S. Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404). Annals of gastroenterological surgery, 5:804-812, 2021

32. Kato K, Ito Y, Nozaki I, Daiko H, Kojima T, Yano M, Ueno M, Nakagawa S, Takagi M, Tsunoda S, Abe T, Nakamura T, Okada M, Toh Y, Shibuya Y, Yamamoto S, Katayama H, Nakamura K, Kitagawa Y. Parallel-Group Controlled Trial of Surgery Versus Chemoradiotherapy in Patients With Stage I Esophageal Squamous Cell Carcinoma. Gastroenterology, 161:1878-1886.e2, 2021

33. Okuma HS, Yonemori K, Kojima Y, Tanioka M, Sudo K, Noguchi E, Hijioka S, Wakakuwa K, Kato K, Hirakawa A, Kuchiba A, Kubo T, Ichikawa H, Yoshida A, Yatabe Y, Nakamura K, Mano H, Yamamoto N, Fujiwara Y. Clinical Utility of Circulating Tumor DNA in Advanced Rare Cancers. Frontiers in oncology, 11:732525, 2021

34. Ri M, Iida S, Maruyama D, Sakabe A, Kamei R, Nakashima T, Tohkin M, Osaga S, Tobinai K, Fukuhara N, Miyazaki K, Tsukamoto N, Tsujimura H, Yoshimitsu M, Miyamoto K, Tsukasaki K, Nagai H. HLA genotyping in Japanese patients with multiple myeloma receiving bortezomib: An exploratory biomarker study of JCOG1105 (JCOG1105A1). Cancer science, 112:5011-5019, 2021

35. Shimizu Y, Murakami N, Chiba T, Kaneda T, Okamoto H, Nakamura S, Takahashi A, Kashihara T, Takahashi K, Inaba K, Okuma K, Nakayama Y, Itami J, Igaki H. High-Dose-Rate Interstitial Brachytherapy for Deeply Situated Gynecologic Tumors Guided by Combination of Transrectal and Transabdominal Ultrasonography: A Technical Note. Frontiers in oncology, 11:808721, 2021

36. Aokage K, Suzuki K, Wakabayashi M, Mizutani T, Hattori A, Fukuda H, Watanabe SI. Predicting pathological lymph node status in clinical stage IA peripheral lung adenocarcinoma. European journal of cardio-thoracic surgery: official journal of the European Association for Cardio-thoracic Surgery, 60:64-71, 2021

37. Shimoyama R, Nakagawa K, Ishikura S, Wakabayashi M, Sasaki T, Yoshioka H, Hashimoto T, Kataoka T, Fukuda H, Watanabe SI. A multi-institutional randomized phase III trial comparing postoperative radiotherapy to observation after adjuvant chemotherapy in patients with pathological N2 Stage III non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG1916 (J-PORT study). Japanese journal of clinical oncology, 51:999-1003, 2021

38. Shimoyama R, Omori S, Nomura S, Kenmotsu H, Takahashi T, Harada H, Ishikura S, Mizutani T, Ando M, Kataoka T, Fukuda H, Ohe Y. A multi-institutional randomized phase III study comparing weekly carboplatin plus nab-paclitaxel and daily low-dose carboplatin as regimens for concurrent chemoradiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer: Japan Clinical Oncology Group Study JCOG1914. Japanese journal of clinical oncology, 51:836-841, 2021

39. Katayama H, Mizusawa J, Fukuda H, Nakamura S, Nakamura K, Saijo N, Yokoyama A, Ohe Y, Shinkai T, Nakagawa K, Abe T, Mitsuoka S, Okamoto H, Yamamoto N, Yoshioka H, Ando M, Tamura T, Takeda K. Prognostic impact of geriatric assessment in elderly patients with non-small cell lung cancer: an integrated analysis of two randomized phase III trials (JCOG1115-A). Japanese journal of clinical oncology, 51:685-692, 2021

40. Abe S, Takizawa K, Oda I, Mizusawa J, Kadota T, Ono H, Hasuike N, Yano T, Yamamoto Y, Horiuchi Y, Nagata S, Yoshikawa T, Terashima M, Muto M. Incidence and treatment outcomes of metachronous gastric cancer occurring after curative endoscopic submucosal dissection of undifferentiated-type early gastric cancer: Japan Clinical Oncology Group study-post hoc analysis of JCOG1009/1010. Gastric cancer: official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 24:1123-1130, 2021

41. Takeyasu Y, Okuma HS, Kojima Y, Nishikawa T, Tanioka M, Sudo K, Shimoi T, Noguchi E, Arakawa A, Mori T, Sunami K, Kubo T, Kohno T, Akihiko Y, Yamamoto N, Yonemori K. Impact of ALK Inhibitors in Patients With ALK-Rearranged Nonlung Solid Tumors. JCO precision oncology, 5:2021

42. Murakami N, Mori T, Machida R, Kodaira T, Ito Y, Shikama N, Konishi K, Matsumoto Y, Murakami Y, Nakamura N, Yamashita H, Yorozu A, Yoshimura M, Inoue K, Nozaki M, Ishikura S, Itami J, Nishimura Y, Kagami Y. Prognostic Value of Epithelial Cell Adhesion Molecules in T1-2N0M0 Glottic Cancer. The Laryngoscope, 131:1522-1527, 2021

43. Nozaki M, Kagami Y, Machida R, Nakamura K, Ito Y, Nishimura Y, Teshima T, Saito Y, Nagata Y, Matsumoto Y, Akimoto T, Hiraoka M. Final analysis of a Multicenter Single-Arm Confirmatory Trial of hypofractionated whole breast irradiation after breast-conserving surgery in Japan: JCOG0906. Japanese journal of clinical oncology, 51:865-872, 2021

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