UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]
Acronym	A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]
Scientific Title	A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]
Scientific Title:Acronym	A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]
Region	Japan

Condition
Condition	Liver Metastases of Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and toxicity of adjuvant XELOX for post curative resection for liver metastasis of colorectal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	3-year Disease-Free Survival
Key secondary outcomes	Overall Survival relative dose intensity Adverse events

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Surgical hepatectomy followed by chemotherapy (XELOX)8cycles. <XELOX> (L-OHP 130 mg/m2 day1 , Capecitabine 2,000mg/m2/day day1-14)
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)Histlogically proven colorectal carcinoma. (2)Curatively resected metastatic liver tumors of colorectal cancer. (3)No extrahepatic metastatis. (4)No history of thermocoagulation therapy and cryotherapy for livermetastasis. (5)Within 42-70 days from the date of liver resection. (6)Age >= 20 years. (7)Performance status(ECOG) of 0-1. (8)Adequate bone marrow, hepatic, renal, cardiac and respiratory functions. (9)Cases that meet all the following criteria (Check all items using the test values of the latest within 14 days prior to entry). 1. Neutrophil count >=1500/mm3 2. Hemoglobin >=8.0g/dL (That you have not done a blood transfusion within 14 days prior to entry). 3. Platelets>=100,000/mm3 4. Total bilirubin <=2.0g/dL 5. AST <=100IU/L 6. AST <=100IU/L 7. Creatinine<=1.5mg/dL (10)Written informed consent.
Key exclusion criteria	(1) Synchronous multiple malignancy (2)Previously treated L-OHP. (3) More than 180days after the last chemotherapy. (4)Pregnant or nursing. (5) Severe peripheral neuropathy. (6) History of severe anaphylaxis or allergia (7)Active infection (8)Severe mental disorder. (9) Severe comorbidity. (10)Systemic steroid user. (11)Patients under treatment with flucytosine,phenytoin,warfarin potassium. (12)Hepatitis B virus infection. (13)Watery diarrhea. (14)Consider not appropriate for the study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naohiro Middle name Last name Tomita
Organization	Hyogo College of Medicine
Division name	Department of Surgery
Zip code	663-8501
Address	Mukogawa-cho 1-1, Nishinomiya-city,Hyogo
TEL	0798-45-6370
Email	ntomita@hyo-med.ac.jp

Public contact
Name of contact person	1st name Naotoshi Middle name Last name Sugimoto
Organization	Osaka International Cancer Institute
Division name	Department of Medical Oncology
Zip code	537-8511
Address	Otemae 3-1-69, chuo-ward ,Osaka
TEL	06-6945-1181
Homepage URL
Email	sugimoto-na2@mc.pref.osaka.jp

Sponsor
Institute	Hyogo College of Medicine, Department of Surgery
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka International Cancer Institute
Address	3-1-69 Otemae, Chuo-ku
Tel	+81669451181
Email	na2-sugimoto@oici.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

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 04 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
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	Terminated
Date of protocol fixation	2014 Year 02 Month 07 Day
Date of IRB	2014 Year 02 Month 07 Day
Anticipated trial start date	2014 Year 02 Month 07 Day
Last follow-up date	2022 Year 02 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 04 Day
Last modified on	2022 Year 04 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015551