UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	S-1 plus Oxaliplatin combination chemotherapy in a stop-and-go fashion for metastatic colorectal cancer
Title of the study (Brief title)	OPTISOX Study
Region	Japan

Condition
Condition	Metastatic colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy in a stop-and-go fashion for metastatic colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Frequency and grade of adverse events
Key secondary outcomes	Duration of disease control, Tumor response rate, Overall survival, Progression-free survival, Disease control rate, Time to treatment failure, R0 resection rate, Compliance

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	S-1, Oxaliplatin
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pathologically confirmed colorectal cancer (adenocarcinoma) 2) Unrecetable recurrent or metastatic colorectal cancer 3) Age 20<= 80> 4) PS(ECOG) 0 or 1 5) Presence of tumor region assessed by image test 30 days before the registry (measureable region is not necessary) 6) No prior chemotherapy and radiotherapy 7) Capability of oral intake 8) Sufficient organ functions WBC>=3000/mm3 and <=12000/mm3 Neutrophils>=1500/mm3 Platelets>=100000/mm3 Hemoglobin>=9.0g/dL Platelets>=100000/mm3 Total bilirubin<2.0mg/dL AST<=100IU/L ALT<=100IU/L Creatinine Clearance>=60mL/min 9) Expected life over 90 days 10)Written informed consent
Key exclusion criteria	1) Medical history of severe anaphylaxis or allergia to any drug 2) Pregnant or lactating woman at any time during study. Men of the fertility hope. 3) Serious infection 4) Severe complications 5) Severe cardiac disease 6) Neuropathy 7) Severe diarrhea 8) Massive pleural or abdominal effusion 9) High grade stenosis at the primary tumor 10) Presence of peritoneal dissemination or peritoneal tuberosity assessed by image test 11) Brain metastasis 12) Double cancer 13) Prior adjuvant chemotherapy with oxaliplatin containing regimen 14) Systemic administration of corticosteroids 15) Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size	40

Research contact person
Name of lead principal investigator	Akihiro Toyokawa
Organization	Yodogawa Christian Hospital
Division name	Department of surgery
Address	2-9-26, Awaji, Higashiyodogawa-ku, Osaka, Japan
TEL
Email

Public contact
Name of contact person
Organization	Yodogawa Christian Hospital
Division name	Department of surgery
Address	2-9-26, Awaji, Higashiyodogawa-ku, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Yodogawa Christian Hospital
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Self funding
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	2010 Year 08 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 06 Month 30 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2013 Year 02 Month 01 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	2010 Year 08 Month 23 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004904