UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective cohort study for assessment of association between imaging changes and outcome after treatment of regorafenib(KSCC1603)
Title of the study (Brief title)	Retrospective cohort study for assessment of imaging changes after use of regorafenib
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We investigate radiological changes in pulmonary or hepatic metastatic lesion after regorafenib treatment in patients with unresectable, advanced/recurrent colorectal cancer, and analyze the exploratory correlation between the radiological changes and outcome.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	We evaluate the radiological changes in pulmonary and hepatic metastatic lesion using CT images scanned within 28 days before regorafenib administration and from 8 weeks to 12 weeks after the administration, and investigate the correlation with prognosis (PFS, OF).
Key secondary outcomes	Subset analysis of each pulmonary and hepatic metastasis in primary endpoint Drug exposure (initial dose, duration and relative dose intensity.) Overall survival Progression free survival (according to investigator assessment including clinical progression) Overall response rate Disease control rate Time to treatment failure Regorafenib related adverse event

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The following metastatic colorectal cancer patients, who had ECOG-PS 0 or 1, treated with regorafenib from Mar 25, 2013 (approval date in Japan) to May 31, 2016. 1. Patients with pulmonary or hepatic metastasis. 2. Patients who receives regorafenib at an initial dose of more than 120mg. 3. Patients whose administration duration of regorafenib excluding interruption is more than 35 days until initial CT from the start of regorafenib administration. 4. Patients who have CT imaged before and after administration in the same site. 5. Patients whose CT was imaged within 28 days before regorafenib administration. 6. Patients whose CT was imaged within 8 -12 weeks after regorafenib administration.
Key exclusion criteria	1. Patients with active double cancer. Carcinoma in situ (intraepithelial carcinoma) or the intramucosal carcinoma equivalent lesion which are concurrent double cancers and heterochronous double cancers within five years of progression free, and the investigator judged to cure by topical treatment, are excluded as the double cancer. 2. Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size	200

Research contact person
Name of lead principal investigator	Eiji Oki
Organization	Graduate School of Medical Sciences, Kyusyu University
Division name	Department of Surgery and Science
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL	092-641-1151
Email	okieiji@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	KSCC Research Secretariat
Organization	Clinical Research Support Center Kyushu
Division name	KSCC Research Secretariat
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan
TEL	092-631-2920
Homepage URL
Email	sakamoto.kscc@gmail.com

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

九州大学病院（福岡県） 国立病院機構九州医療センター（福岡県） 公立学校共済組合九州中央病院（福岡県） 済生会福岡総合病院（福岡県） 製鉄記念八幡病院（福岡県） 国立病院機構福岡東医療センター（福岡県） 久留米大学（福岡県） 長崎大学（長崎県） 光晴会病院（長崎県） 大分県立病院（大分県） 国立病院機構別府医療センター（大分県） 中津市立中津市民病院（大分県） 鹿児島厚生連病院（鹿児島県） 南風病院（鹿児島県） 出水郡医師会広域医療センター（鹿児島県） 琉球大学（沖縄県） 飯塚病院（福岡県） 宗像医師会病院（福岡県） 熊本市民病院（熊本県） 神戸市立医療センター中央市民病院（兵庫県） 高知医療センター（高知県） 岡山労災病院（岡山県） 九州大学病院別府病院（大分県） 国立病院機構九州がんセンター（福岡県） JCHO九州病院（福岡県） 佐賀大学（佐賀県） 那覇市立病院（沖縄県） 慈泉会相澤病院（長野県） 薫風会佐野病院（兵庫県） 北海道大学（北海道） 香川大学（香川県） NTT東日本札幌病院（北海道） 公立八女総合病院（福岡県） 熊本大学医学部附属病院（熊本大学） JCHO人吉医療センター（熊本県） 国立病院機構大分医療センター（大分県） 松山赤十字病院（愛媛県） 神戸大学医学部附属病院（兵庫県） 岡山大学病院（岡山県） 山口県立総合医療センター（山口県） 手稲渓仁会病院（北海道） 釧路労災病院（北海道） 香川大学医学部附属病院（香川県） 市立函館病院（北海道） 静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Outcome measured The following clinical information is obtained. 1) Age 2) Gender 3) Height 4) Weight 5) ECOG-PS 6) Information regarding to clinical history (1) Primary lesion (2) Metastatic lesion (presence or absence of pulmonary metastasis, hepatic metastasis, and other organ metastasis) (3) Treatment period until the start of regorafenib treatment (Either long during the period from initial chemotherapy start excluding adjuvant therapy or period from the resection of metastatic lesion) (4) Clinical stage (5) Presence or absence of RAS mutation (6) Tumor marker level (change) (7) Number of pre-treatment regimen (8) Pre-treatment history (such as regimen, start date and finish date, TAS-102 administration 7) Information about regorafenib administration (such as dose, duration, total dose) 8) CT findings before administration (within 28 days before regorafenib administration) after administration (imaged within 8 - 12 weeks after regorafenib administration) (1) Pulmonary metastatic lesion: presence or absence of cavitation and appearance of cavitation after administration, or enlargement if there is a cavitation before administration. (2) Hepatic metastatic lesion: CT value changes before and after administration 9) Anti tumor effect based on RECIST v1.1 10) Adverse events after regorafenib administration 11) Port-treatment after regorafenib treatment and drug used. 12) Overall survival, progression free survival

Management information
Registered date	2016 Year 07 Month 25 Day
Last modified on	2019 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026873