UMIN-CTR Clinical Trial

Public title

Retrospective cohort study for assessment of association between imaging changes and outcome after treatment of regorafenib(KSCC1603)

Acronym

Retrospective cohort study for assessment of imaging changes after use of regorafenib

Scientific Title

Retrospective cohort study for assessment of association between imaging changes and outcome after treatment of regorafenib(KSCC1603)

Scientific Title:Acronym

Retrospective cohort study for assessment of imaging changes after use of regorafenib

Region

Japan

Condition

Colorectal Cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Eiji Oki

Organization

Graduate School of Medical Sciences, Kyusyu University

Division name

Department of Surgery and Science

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan

TEL

092-641-1151

Email

okieiji@surg2.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	KSCC Research Secretariat

Organization

Clinical Research Support Center Kyushu

Division name

KSCC Research Secretariat

Zip code

Address

3-1-1, Maidashi, Higashi-Ku, Fukuoka 812-8582, Japan

TEL

092-631-2920

Homepage URL

Email

sakamoto.kscc@gmail.com

Institute

Kyushu Study group of Clinical Cancer

Institute

Department

Personal name

Organization

Bayer Yakuhin Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

07

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

07

Month

05

Day

Date of IRB

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

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

Registered date

2016

Year

07

Month

25

Day

Last modified on

2019

Year

01

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026873