UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004122 |
|---|---|
| Receipt number | R000004902 |
| Scientific Title | Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX in previously treated patients with metastatic colorectal cancer (ORION study) |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2018/09/20 08:22:33 |
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Basic information
Public title
Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX in previously treated patients with metastatic colorectal cancer (ORION study)
Acronym
Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX (ORION study)
Scientific Title
Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX in previously treated patients with metastatic colorectal cancer (ORION study)
Scientific Title:Acronym
Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX (ORION study)
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the time to treatment failure (TTF) of standard triweekly XELOX and biweekly XELOX 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
time to treatment failure
Key secondary outcomes
1)evaluation of fatigue based on Cancer Fatigue Scale
2)relative dose intensity
3)response rate(Disease control rate)
4)progression free survival
5)adverse event
6)overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oxaliplatin 130mg/m2 day1
Capacitabine 2000mg/m2 day1-14
every 3 weeks
Interventions/Control_2
Oxaliplatin 85mg/m2 day1
Capacitabine 2000mg/m2 day1-7
every 2 weeks
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) colorectal cancer that is not amenable to curative resection and have previously received chemotherapy containing oxaliplatin (e.g. FOLFOX4, mFOLFOX6, or XELOX) and irinotecan (e.g. FOLFIRI, IRIS, or irinotecan monotherapy).
3) patients will not have received oxaliplatin immediately before this trial.
4) at least stable disease(SD) during previous oxaliplatin-based therapy.
5) Presence of target lesion according to the RECIST.
6) ECOG Performance status(PS) of 0-2.
7) age of 20 years or older.
8) A life expectancy of more than 12 week.
9) no severe organ failure: and suitable results of all laboratory test performed within 7 days before enrollment.
WBC <= 2,000/mm3 and <= 12,000/mm3
neutrophil >= 1,000/mm3
platelet >= 100,000/mm3
AST and ALT <= 3 times the institutional upper limit of normal or <= 5 times if the patient has liver metastasis
T-Bil <= 1.5 times the institutional upper limit of normal
Cr <= the institutional upper limit of normal
10) Written informed consent will be obtained from each patient before enrollment.
Key exclusion criteria
1) blood transfusion or administration of blood products or hemopoietic factors (e.g. G-CSF) within 7 days before enrollment.
2) a history of serious drug hypersensitivity or serious drug allergy.
3) Grade 3 or 4 sensory neuropathy.
4) PD within the previous 2 months during prior oxaliplatin-based therapy.
5) less than 3 weeks after administration of folic acid preparation in prior chemotherapy
6) active double cancer within the past 5 years
7) uncontrolled pleural effusion or ascites
8) pericardial effusion
9) clinically important infection or suspected infection in febrile patients.
10) brain metastasis
11) significant electrocardiographic abnormality
12) clinically significant heart disease
13) severe pulmonary disease
14) fresh gastrointestinal bleeding
15) diarrhea(watery) or diarrhea that interferes with daily activities for patients with a stoma.
16) bleeding or intestinal obstruction
17) central nervous system disorders
18) senile dementia
19) patients who are judged to be unsuitable for this trial due to clinically significant mental / psychological disease etc
20) uncontrolled diabetes or diabetic neuropathy.
21) women who are pregnant, lactating, or wish to become pregnant.
22) patients who are judged to be ineligible by principal investigator for any other reason.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Mishima |
Organization
Aichi Medical Unoversity
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 | Mai Hatta |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Young Leaders' Program in Medical Administration
Zip code
Address
65 Tsurumai Showa-ku Nagoya
TEL
052-744-2442
Homepage URL
m-hatta@med.nagoya-u.ac.jp
Sponsor or person
Institute
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department
Personal name
Funding Source
Organization
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2010 | Year | 09 | 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
RESULTS:
A total of 46 patients were enrolled in the trial-22 patients were randomly assigned to the Q3W group and 23 to the Q2W group. The median TTF was 3.4 months in both groups (hazard ratio [HR] 1.053; p = 0.880). The median PFS and OS were 3.3 and 9.2 months in the Q2W group and 4.3 and 12.1 months in the Q3W group, respectively (HR 1.15; p = 0.153 and 0.672; p = 0.836). The most common grade 3-4 AEs in the Q3W and Q2W groups were fatigue (27.3 vs 21.7), neuropathy (9.1 vs 0 %) and diarrhea (9.1 vs 0 %), respectively.
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
| 2010 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Int J Clin Oncol. 2015 Oct 16. [Epub ahead of print]
Multicenter randomized phase II clinical trial of oxaliplatin reintroduction as a third- or later-line therapy for metastatic colorectal cancer-biweekly versus standard triweekly XELOX (The ORION Study).
Matsuda C, Honda M, Tanaka C, Fukunaga M, Ishibashi 5, Munemoto Y, Hata T, Bando H, Oshiro M, Kobayashi M, Tokunaga Y, Fujii A, Nagata N, Oba K, Mishima H.
Management information
Registered date
| 2010 | Year | 08 | Month | 29 | Day |
Last modified on
| 2018 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004902
