UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of oxaliplatin reintroduction treated with biweekly S-1 plus oxaliplatin (SOX) in patients with metastatic colorectal cancer.(ORION2)
Title of the study (Brief title)	ORION2
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of oxaliplatin reintroduction treated with biweekly SOX in metastatic colorectal cancer patients previously received both oxaliplatin and irinotecan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Overall survival Time to treatment failure Response rate Dose intensity Relative dose intensity Adverse event

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	Oxaliplatin 85 mg/m2, day1 S-1 80-120 mg/day, day 1-7 or alternate-day every 2 weeks
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) Histopathologically confirmed colorectal cancer 2) Previously received chemotherapy containing oxaliplatin and irinotecan 3) Not received oxaliplatin immediately before this trial 4) At least stable disease(SD) during previous oxaliplatin-based tratment 5) 6 months or over from the last introduction of oxaliplatin 6) Peripheral neuropathy<=grade1 7) Be able to take oral drugs 8) Mesurable lesion according to the RECIST 9) Age >= 20 years old 10) PS 0-2 11) A life expectancy of more than 12 weeks 12) No severe impairment of major organs (bone marrow,heart,lungs,liver,kidneys, etc) laboratory data within 14 days WBC >=2,000/mm3 and <= 12,000/mm3 Neutrophil >=1,000/mm3 Hemoglobin >=8.0 g/dL Platelet >=100,000/mm3 AST, ALT <=ULNx3.0 T-Bil <=ULNx1.5 Cr <=ULN Creatinine clearance >=40 mL/min 13) Written informed consent
Key exclusion criteria	1) Serious sensory abnormality or dysfunction 2) PD within 2 months during previous oxaliplatin-based therapy 3) Serious drug allergy 4) Presence of other active malignancies or a history of malignancies within the past 5 years 5) Blood transfusion or hemopoietic factors (G-CSF) within 7 days 6) Uncontrolled pleural effusion, ascites, or pericardial effusion 7) Clinically significant infection 8) Brain metastasis 9) Clinically significant heart disease (myocardial infarction within 12 months, etc) 10) Serious complication(intestinal obstruction, interstitial pneumonia, uncontrolled diabetes, peptic ulcer hypertension, renal failure, hepatic failure) 11) Fresh GI bleeding 12) Watery diarrhea 13) Central nervous system disorders 14) Dementia or clinically significant mental/neurological disorders 15) Patients who need flucytosine, phenytoin or warfarin potassium 16) Women who are pregnant, lactating, or wish to become pregnant 17) Investigator's judgement
Target sample size	40

Research contact person
Name of lead principal investigator	Hideyuki Mishima
Organization	Aichi Medical University
Division name	Cancer Center
Address	1-1, Yazakokarimata Nagakute, Aichi
TEL	0561-62-3311
Email	hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person	Yumi Miyashita
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Division name	Aichi branch
Address	YK bldg. 6F, 1-7-9, Hanenishi, Okazaki, Aichi
TEL	0564-64-7300
Homepage URL
Email	miya@ecrin.or.jp

Sponsor
Institute	Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department

Funding Source
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Organization
Division
Category of Funding Organization	Non profit foundation
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	2014 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 25 Day
Anticipated trial start date	2014 Year 03 Month 01 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	Published
URL releasing results
Results	Biweekly S-1 plus oxaliplatin (SOX) reintroduction in previously treated metastatic colorectal cancer patients (ORION 2 study): a phase II study to evaluate the efficacy and safety. Hiroaki Tanioka. et al; Int J Clin Oncol. 2019 Feb 18. [Epub ahead of print] RESULTS: A total of 41 patients from 12 institutes were enrolled. The median PFS and OS survival were 3.3 months (95% confidence interval [CI] 2.7-4.2) and 10.1 months (8.3-14.6), and response rate and disease control rate were 10.0% and 65.0%, respectively. Grade 3 AEs included thrombocytopenia (5.0%), anorexia (5.0%), pneumonia (5.0%) and fatigue (5.0%). There were no cases of grade 4 AEs or treatment-related death.
Other related information

Management information
Registered date	2014 Year 02 Month 26 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014829