UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Acronym	Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Scientific Title	Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Scientific Title:Acronym	Multicenter observational study on the connection between sarcopenia and the curability of chemotherapy in advanced or recurrent colorectal cancer.
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is to investigate the correration of skeletal mass and fat tissue mass calculated by CT with Overall survival, Progression free survival, Response rate, Adverse event rate for the patients registered in KSCC0701, 0801, 0802, 0902, 1002, 1101 who had progressive or reccurent colorectal cancer.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcomes are Overall survival period, relapse free survival period, response rate, Adverse event rate. We are going to investigate the correration the sarcopenia, the rate of skeletal muscle loss and subcutaneous or visceral fat with the primary outcomes.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patient is found to have colorectal cancer histopathologically. 2. The tumor is too progressive or reccurent and no resectable. It is judged by the attending doctor. 3. First line systemic chemotherapy is administered. 4. The patients registered in KSCC0701, 0801, 0802, 0902, 1002, 1101 have the image of CT before the start of chemotherapy and 60 to 120 days or 150 to 210 after chemotherapy.
Key exclusion criteria	It is the excluded case that is judged irreverent by the attending doctor.
Target sample size	249

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Oki
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science, Graduate School of Medical Sciences
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-409-3500
Email	sanae.sakamoto@ks-cc.or.jp

Public contact
Name of contact person	1st name KSCC Middle name Last name Research Secretariat
Organization	Kyushu Study group of Clinical Cancer
Division name	KSCC Research Secretariat
Zip code	812-8582
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL	092-409-3500
Homepage URL
Email	sanae.sakamoto@ks-cc.or.jp

Sponsor
Institute	Kyushu Study group of Clinical Cancer
Institute
Department

Funding Source
Organization	Kyushu Study group of Clinical Cancer
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyushu University Ethics Review Board
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel	092-641-1151
Email	byssien@jimu.kyushu-u.ac.jp

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）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	249
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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 24 Day
Date of IRB	2017 Year 08 Month 02 Day
Anticipated trial start date	2017 Year 05 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Skeletal mass area of lower L3 level(m2), Visceral fat area(m2), Subcutaneous fat area(m2), Abdominal circumference(cm), skeletal mass index(SMI=skeletal mass area/Height2), Visceral fat area(VFA)/Subcutaneous fat area(SFA) Patients' information Age, Sex, Birth date, Registered number, Body mass index(BMI=Weight/Height2), Labo data(AST, ALT, ALP, Na, K, Alb, Cr, T.Bil, CEA, CA19-9, WBC, Neut, Plt, Hb) Disease information of the patients' Clinical stage before treatment, Location of the tumor, History of surgery for the colorectal cancer(Ope date, The histopathological diagnosis), History of the chemotherapy(Regimen, dose, period, Best overall response) Treatment outcome Response rate(RR), Progression free survival(PFS), Overall survival(OS), Adverse event rate

Management information
Registered date	2017 Year 05 Month 31 Day
Last modified on	2019 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031498