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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004122
Receipt No. 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

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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
Email 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&#39; Program in Medical Administration
Zip code
Address 65 Tsurumai Showa-ku Nagoya
TEL 052-744-2442
Homepage URL
Email m-hatta@med.nagoya-u.ac.jp

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004902

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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