UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013277 |
|---|---|
| Receipt number | 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 15:32:48 |
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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
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
miya@ecrin.or.jp
Sponsor or person
Institute
Epidemiological and Clinical research Information Network (ECRIN)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014829
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
