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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013277
Receipt No. R000014829
Scientific Title Phase II study of oxaliplatin reintroduction treated with biweekly S-1 plus oxaliplatin (SOX) in patients with metastatic colorectal cancer.(ORION2)
Date of disclosure of the study information 2014/03/01
Last modified on 2019/03/04

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Basic information
Public title Phase II study of oxaliplatin reintroduction treated with biweekly S-1 plus oxaliplatin (SOX) in patients with metastatic colorectal cancer.(ORION2)
Acronym ORION2
Scientific Title Phase II study of oxaliplatin reintroduction treated with biweekly S-1 plus oxaliplatin (SOX) in patients with metastatic colorectal cancer.(ORION2)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Miyashita
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name Aichi branch
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.


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 Completed
Date of protocol fixation
2014 Year 02 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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