Prospective multicenter disease registry using SCRUM-Japan as an external control group for marketing authorization for pharmaceuticals

Conditions

Unresectable solid malignancies

Kato T, Matsubara N, Shiota M, Eto M, Osawa T, Abe T, Shinohara N, Yasumizu Y, Tanaka N, Oya M, Nishimoto K, Hayashi T, Nakayama M, Kojima T, Namikawa K, Fujisawa T, Okano S, Hida E, Nakamura Y, Bando H, Yoshino T, Nonomura N.

2022-12-091 citations

10.1186/s12885-022-10398-6

Circulating tumor DNA-guided treatment with pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer: a phase 2 trial.

Nakamura Y, Okamoto W, Kato T, Esaki T, Kato K, Komatsu Y, Yuki S, Masuishi T, Nishina T, Ebi H, Sawada K, Taniguchi H, Fuse N, Nomura S, Fukui M, Matsuda S, Sakamoto Y, Uchigata H, Kitajima K, Kuramoto N, Asakawa T, Olsen S, Odegaard JI, Sato A, Fujii S, Ohtsu A, Yoshino T.

2021-11-11171 citations

10.1038/s41591-021-01553-w

Pertuzumab plus trastuzumab and real-world standard of care (SOC) for patients (pts) with treatment refractory metastatic colorectal cancer (mCRC) with <i>HER2</i> (<i>ERBB2</i>) amplification (amp) confirmed by tumor tissue or ctDNA analysis (TRIUMPH, EPOC1602).

Wataru Okamoto, Yoshiaki Nakamura, Takeshi Kato, Taito Esaki, Masato Komoda et al. (20 authors)

Journal of Clinical Oncology2021-05-2012 citations

10.1200/jco.2021.39.15_suppl.3555

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible, subjects must meet all the following inclusion criteria of 1)-4): 1) Has unresectable solid malignancies. 2) Has undergone to a comprehensive genomic profile that Next Generation Sequencing or related research for scrum-japan. (i) Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (UMIN000010234) (ii) The Nationwide Cancer Genome Screening Project for Gastrointestinal Cancer in Japan (SCRUM-Japan GI-SCREEN)(UMIN000016343) (iii)(SCRUM-Japan GI Screen 2015-01-Non-CRC) (UMIN000016344) (iv)HER2 screening study for metastatic colorectal cancer (additional studies of GI-SCREEN 2013-01-CRC) (v)A screening study of HER2 expression for biliary tract cancer (vi)Research on Liquid Biopsy in Patients with Gastrointestinal and Abdominal Malignancies, Including Colorectal Cancer (vii)Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (viii)Multicenter Study to Profile and Monitor Cancer-related Genomic Alterations in Circulating Tumor DNA and the Gut Microbiome in Advanced Solid Malignancies (ix)A Prospective Observational Study on the Efficacy of Multiplex Genetic Analysis by Means of a Next-Generation Sequencer Using Cell-Free DNA (x)A Multicenter Study on Biomarker Development Utilizing AI Multiomics for Patients with Advanced Solid Malignant Tumors (XX)Lung Cancer Genomic Screening Project for Individualized Medicine Molecular Testing for Resistant Tumors to Systemic Therapy (XXX)Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (XL)Multi-institutional collaborative study aiming to elucidate the spatiotemporal molecular profiles for patients with malignant tumor 3) The specific genetic alteration in the gene analysis identified 2), see Other related information. 4) Is at least 20 years of age at the time of registration.

Exclusion criteria

Exclusion criteria: Subjects have any reason, in the opinion of the investigator, that would preclude participation in this research.

Design outcomes

Primary

Measure	Time frame
Response Rate	—

Secondary

Measure	Time frame
Progression Free Survival, Duration of Response, Time to Treatment Failure, Disease Control Rate, and Overall Survival	—

Countries

Japan

Contacts

Public ContactHideaki Bando

National Cancer Center Hospital East, Department of Gastroenterology and GI Oncology, Translational Research Support Office

hbando@east.ncc.go.jp04-7133-1111

Outcome results