UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized control trial of herbal medicine for cancer patients that examined influence of IL-6 and cachexy.
Title of the study (Brief title)	Influence of the herbal medicine
Region	Japan

Condition
Condition	colorectal cancer, pancreatic cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Relative dose intensity of first line chemothrapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MTD, RD,IL-6
Key secondary outcomes	QOL Nutritional assessment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hochuekkitou, gosyajinnkigan, keisibukuryogan
Interventions/Control_2	control
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	"(1) Histological proven adenocarcinoma (2) possible oral intake (3) unresectable corolectal and pancreatic cancer (4) KRAS mutation untested or negative or positive (5) PS 0-1 (6) Adequate organ function (7) Written informed consent from patients (8) Capcitabine + Oxalipltain + Bevacizumab regimen in patients with colorectal cancer (9) Gemcitabine + Nab-paclitaxel in patients with pancreatic cancer (10) Best surpotive care in study2"
Key exclusion criteria	"(1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy. (2) Past history of severe hypersensitivity to drugs (3) Body temperature of over 38 degrees Celsius or active infection (4) serious bone marrow suppression, a renal damage or a liver damage (5) Severe complications (6) Pregnant women, women with the possibility of the pregnancy, or men who want their partners to become pregnant (7) Psychological disorder (8) Patients judged inappropriate for the study by the physicians "
Target sample size	60

Research contact person
Name of lead principal investigator	Masahiro Gotou
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1221
Email	in2030@osaka-med.ac.jp

Public contact
Name of contact person	Toshifumi Yamaguchi
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1221
Homepage URL
Email	ctc008@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College Hospital
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 30 Day
Anticipated trial start date	2017 Year 12 Month 30 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

Management information
Registered date	2018 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035748