Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients

Takaaki Mizuno; Tatsuya Yoshida; Kuniko Sunami; Takafumi Koyama; Natsuko Okita; Takashi Kubo; Kazuki Sudo; Tatsunori Shimoi; Hideki Ueno; Eiko Saito; Kota Katanoda; Taro Shibata; Kan Yonemori; Takuji Okusaka; Narikazu Boku; Yuichiro Ohe; Yukihiko Hiroshima; Makoto Ueno; Yasutoshi Kuboki; Toshihiko Doi; Kenichi Nakamura; Takashi Kohno; Yasushi Yatabe; Noboru Yamamoto

doi:10.1093/jjco/hyab159

Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients

Takaaki Mizuno, Tatsuya Yoshida, Kuniko Sunami, Takafumi Koyama, Natsuko Okita, Takashi Kubo, Kazuki Sudo, Tatsunori Shimoi, Hideki Ueno, Eiko Saito, Kota Katanoda, Taro Shibata, Kan Yonemori, Takuji Okusaka, Narikazu Boku, Yuichiro Ohe, Yukihiko Hiroshima, Makoto Ueno, Yasutoshi Kuboki, Toshihiko DoiKenichi Nakamura, Takashi Kohno, Yasushi Yatabe, Noboru Yamamoto

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

Comprehensive genomic profiling has been approved for use in patients with advanced solid tumours; however, it is only indicated in advanced solid tumour patients without available standard chemotherapeutic treatment or those who have completed standard treatments in Japan, and there are no available data on the clinical feasibility and utility of comprehensive genomic profiling in treatment-naive patients. This multicentre, single-arm, prospective study aims to evaluate the feasibility and utility of the OncoGuide NCC Oncopanel System in treatment-naive patients with six advanced major malignancies: non-small cell lung cancer, breast cancer, gastric cancer, colon cancer, pancreatic cancer and biliary tract cancer (NCCH1908). This study (study cohort) will be compared with the other prospective observational study (control cohort), which enrols patients not receiving comprehensive genomic profiling prior to initial systemic treatment. A total of 200 patients will be enrolled in the study over 21 months. This study has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (UMIN000040743). Clinical trial registration: This study, initiated in June 2020, has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (registration number: UMIN000040743). We plan to enrol a total of 200 patients over a period of 21 months.

Original language	English
Pages (from-to)	1757-1760
Number of pages	4
Journal	Japanese Journal of Clinical Oncology
Volume	51
Issue number	12
DOIs	https://doi.org/10.1093/jjco/hyab159
State	Published - 1 Dec 2021
Externally published	Yes

Keywords

actionable genomic alteration
comprehensive genomic profiling
first-line treatment
molecular targeted therapy
solid tumour

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10.1093/jjco/hyab159

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Mizuno, T., Yoshida, T., Sunami, K., Koyama, T., Okita, N., Kubo, T., Sudo, K., Shimoi, T., Ueno, H., Saito, E., Katanoda, K., Shibata, T., Yonemori, K., Okusaka, T., Boku, N., Ohe, Y., Hiroshima, Y., Ueno, M., Kuboki, Y., ... Yamamoto, N. (2021). Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients. Japanese Journal of Clinical Oncology, 51(12), 1757-1760. https://doi.org/10.1093/jjco/hyab159

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title = "Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients",

abstract = "Comprehensive genomic profiling has been approved for use in patients with advanced solid tumours; however, it is only indicated in advanced solid tumour patients without available standard chemotherapeutic treatment or those who have completed standard treatments in Japan, and there are no available data on the clinical feasibility and utility of comprehensive genomic profiling in treatment-naive patients. This multicentre, single-arm, prospective study aims to evaluate the feasibility and utility of the OncoGuide NCC Oncopanel System in treatment-naive patients with six advanced major malignancies: non-small cell lung cancer, breast cancer, gastric cancer, colon cancer, pancreatic cancer and biliary tract cancer (NCCH1908). This study (study cohort) will be compared with the other prospective observational study (control cohort), which enrols patients not receiving comprehensive genomic profiling prior to initial systemic treatment. A total of 200 patients will be enrolled in the study over 21 months. This study has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (UMIN000040743). Clinical trial registration: This study, initiated in June 2020, has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (registration number: UMIN000040743). We plan to enrol a total of 200 patients over a period of 21 months.",

keywords = "actionable genomic alteration, comprehensive genomic profiling, first-line treatment, molecular targeted therapy, solid tumour",

author = "Takaaki Mizuno and Tatsuya Yoshida and Kuniko Sunami and Takafumi Koyama and Natsuko Okita and Takashi Kubo and Kazuki Sudo and Tatsunori Shimoi and Hideki Ueno and Eiko Saito and Kota Katanoda and Taro Shibata and Kan Yonemori and Takuji Okusaka and Narikazu Boku and Yuichiro Ohe and Yukihiko Hiroshima and Makoto Ueno and Yasutoshi Kuboki and Toshihiko Doi and Kenichi Nakamura and Takashi Kohno and Yasushi Yatabe and Noboru Yamamoto",

year = "2021",

month = dec,

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doi = "10.1093/jjco/hyab159",

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Mizuno, T, Yoshida, T, Sunami, K, Koyama, T, Okita, N, Kubo, T, Sudo, K, Shimoi, T, Ueno, H, Saito, E, Katanoda, K, Shibata, T, Yonemori, K, Okusaka, T, Boku, N, Ohe, Y, Hiroshima, Y, Ueno, M, Kuboki, Y, Doi, T, Nakamura, K, Kohno, T, Yatabe, Y & Yamamoto, N 2021, 'Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients', Japanese Journal of Clinical Oncology, vol. 51, no. 12, pp. 1757-1760. https://doi.org/10.1093/jjco/hyab159

Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients. / Mizuno, Takaaki; Yoshida, Tatsuya; Sunami, Kuniko et al.
In: Japanese Journal of Clinical Oncology, Vol. 51, No. 12, 01.12.2021, p. 1757-1760.

Research output: Contribution to journal › Article › peer-review

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T1 - Study protocol for NCCH1908 (UPFRONT-trial)

T2 - A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients

AU - Mizuno, Takaaki

AU - Yoshida, Tatsuya

AU - Sunami, Kuniko

AU - Koyama, Takafumi

AU - Okita, Natsuko

AU - Kubo, Takashi

AU - Sudo, Kazuki

AU - Shimoi, Tatsunori

AU - Ueno, Hideki

AU - Saito, Eiko

AU - Katanoda, Kota

AU - Shibata, Taro

AU - Yonemori, Kan

AU - Okusaka, Takuji

AU - Boku, Narikazu

AU - Ohe, Yuichiro

AU - Hiroshima, Yukihiko

AU - Ueno, Makoto

AU - Kuboki, Yasutoshi

AU - Doi, Toshihiko

AU - Nakamura, Kenichi

AU - Kohno, Takashi

AU - Yatabe, Yasushi

AU - Yamamoto, Noboru

PY - 2021/12/1

Y1 - 2021/12/1

N2 - Comprehensive genomic profiling has been approved for use in patients with advanced solid tumours; however, it is only indicated in advanced solid tumour patients without available standard chemotherapeutic treatment or those who have completed standard treatments in Japan, and there are no available data on the clinical feasibility and utility of comprehensive genomic profiling in treatment-naive patients. This multicentre, single-arm, prospective study aims to evaluate the feasibility and utility of the OncoGuide NCC Oncopanel System in treatment-naive patients with six advanced major malignancies: non-small cell lung cancer, breast cancer, gastric cancer, colon cancer, pancreatic cancer and biliary tract cancer (NCCH1908). This study (study cohort) will be compared with the other prospective observational study (control cohort), which enrols patients not receiving comprehensive genomic profiling prior to initial systemic treatment. A total of 200 patients will be enrolled in the study over 21 months. This study has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (UMIN000040743). Clinical trial registration: This study, initiated in June 2020, has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (registration number: UMIN000040743). We plan to enrol a total of 200 patients over a period of 21 months.

AB - Comprehensive genomic profiling has been approved for use in patients with advanced solid tumours; however, it is only indicated in advanced solid tumour patients without available standard chemotherapeutic treatment or those who have completed standard treatments in Japan, and there are no available data on the clinical feasibility and utility of comprehensive genomic profiling in treatment-naive patients. This multicentre, single-arm, prospective study aims to evaluate the feasibility and utility of the OncoGuide NCC Oncopanel System in treatment-naive patients with six advanced major malignancies: non-small cell lung cancer, breast cancer, gastric cancer, colon cancer, pancreatic cancer and biliary tract cancer (NCCH1908). This study (study cohort) will be compared with the other prospective observational study (control cohort), which enrols patients not receiving comprehensive genomic profiling prior to initial systemic treatment. A total of 200 patients will be enrolled in the study over 21 months. This study has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (UMIN000040743). Clinical trial registration: This study, initiated in June 2020, has been registered in the UMIN Clinical Trials Registry (www.umin.ac.jp/ctr/) (registration number: UMIN000040743). We plan to enrol a total of 200 patients over a period of 21 months.

KW - actionable genomic alteration

KW - comprehensive genomic profiling

KW - first-line treatment

KW - molecular targeted therapy

KW - solid tumour

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Mizuno T, Yoshida T, Sunami K, Koyama T, Okita N, Kubo T et al. Study protocol for NCCH1908 (UPFRONT-trial): A prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients. Japanese Journal of Clinical Oncology. 2021 Dec 1;51(12):1757-1760. doi: 10.1093/jjco/hyab159