UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of oxaliplatin reintroduction and the biweekly XELOX in previously treated patients with metastatic colorectal cancer (ORION study)
Title of the study (Brief title)	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	Hideyuki Mishima
Organization	Aichi Medical Unoversity
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	Mai Hatta
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Young Leaders' Program in Medical Administration
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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