UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of predictive biomarker and analysis of correlations between toxicities and SNPs that can be related to pharmacokinetics, in trifluridine/tipiracil hydrochloride therapy for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer
Title of the study (Brief title)	Analysis of biomarker for trifluridine/tipiracil hydrochloride therapy
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To identify novel tissue or serum biomarkers, and SNPs, which can predict efficacy or toxicities in treatment of trifluridine/tipiracil hydrochloride for previously fluoropyrimidine-treated elderly patients with unresectable or recurrent colorectal cancer
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Tissue biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from trifluridine/tipiracil hydrochloride therapy 2. Serum biomarkers including mutation, gene expression, and DNA methylation that correlate with efficacy from trifluridine/tipiracil hydrochloride therapy 3. SNPs that correlate with toxicities from trifluridine/tipiracil hydrochloride therapy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Gene
Interventions/Control_1	Nucleic acid from tumor tissues and serum SNPs
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	65 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients are required to fulfill the following criteria for eligibility. 1) Histologically confirmed adenocarcinoma of colon or rectum. 2) One or more target lesions confirmed by CT or other imaging within 28 days before the registration. 3) One or more previous drug treatments including fluoropyrimidine-based regimen. 4) The Eastern Cooperative Oncology Group Performance Status of 0-2. 5) Ingestible. 6) Estimated to survive for three months or more since registration. 7) Written informed consent. 8) Age 65-84. 9) Fulfill the following hematological and biochemical data obtained in the most recent blood test. WBC 3,000 /mm3 or more, neutrophil 1,500 /mm3 or more, platelets 10.0*104 /mm3 or more, hemoglobin 8.0 g/dl or more, AST 100 IU/l or less, ALT 100 IU/l or less, and T-Bil 2.0 g/dl or less. Patients should not receive transfusion or granulocyte colony stimulating factor within 14 days before the blood test. 10) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.
Key exclusion criteria	Patients who fulfill the following criteria for exclusion are excluded. 1) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer. 2) Active infection and inflammation (the body temperature with >= 38.0 degree of celsius). 3) Active hepatitis. 4) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, and uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis. 5) Chronic diarrhea (>= 4 times a day, or watery). 6) Active gastrointestinal bleeding. 7) Effusion that requires drainage. 8) Thoracotomy, laparotomy, or laparoscopic surgery within 28 days before registration. 9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs. 10) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	Chikashi Ishioka
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Clinical Oncology
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-8543
Email	chikashi@tohoku.ac.jp

Public contact
Name of contact person	Hideki Shimodaira
Organization	Tohoku Clinical Oncology Research and Education Society (T-CORE)
Division name	Administration Office
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-8599
Homepage URL
Email	hideki.shimodaira.c4@tohoku.ac.jp

Sponsor
Institute	Tohoku Clinical Oncology Research and Education Society (T-CORE)
Institute
Department

Funding Source
Organization	Tohoku Clinical Oncology Research and Education Society (T-CORE)
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	2016 Year 04 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 30 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
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	2016 Year 04 Month 01 Day
Last modified on	2017 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025078