UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)
Title of the study (Brief title)	Randomized phase II study of adding steroid for prevention of venous pain in CRC patients who are receiving oxaliplatin through peripheral vein (APOLLO)
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 preventive effect of combined administration of steroid and oxaliplatin on peripheral venous pain .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The incidence of venous pain:Grade>=2
Key secondary outcomes	1)time to occurrence of venous pain 2)adverse events 3)response rate 4)time to treatment failure 5)overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	Prevention
Type of intervention	Medicine
Interventions/Control_1	XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Oxaliplatin is combined with dexamethasone (2 mg).
Interventions/Control_2	XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 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)Chemotherapy-naive patients. Adjuvant chemotherapy by fluoropyrimidine alone is eligible. 3)Measurable lesion by RECIST 4)Oxaliplatin administration by peripheral vein. 5)Not receiving analgesic treatment. 6) ECOG Performance status(PS) of 0-1 7)age of 20 years or older. 8)A life expectancy of more than 12 week. 9)No severe impairment of major organs (bone marrow, heart, lungs, liver, kidneys, etc.), laboratory data within 14 days WBC >=3,000/mm3 and <=12,000mm3 neutrophil >=1,500/mm3 hemoglobin >=8.0g/dL platelet >=100,000/mm3 AST and ALT <=2.5 ULN or <=5.0 ULN if the patient has liver metastasis T-Bil <=1.5 ULN Cr <=UNL Creatinine clearance >=50 mL/min 10)Written informed consent.
Key exclusion criteria	1)Serious drug allergy. 2)Neuropathy or sensory dysfunction. 3)Pain in the arm. 4)Current analgesic treatment. 5)Active double cancer within the past 5 years. 6)Serious psychological disease. 7)Steroid treatment. 8)blood transfusion or hemopoietic factors (e.g. G-CSF) within 7 days . 9)Pleural effusion, ascites, or pericardial effusion. 10)Clinically significant infection. 11)brain metastasis 12)Clinically significant heart disease (myocardial infarction within 12 months, etc.). 13)Clinically significant pulmonary disease 14)bleeding that requires medication or transfusion. 15)Watery diarrhea. 16)Ileus or bowel obstruction. 17)Central nervous system disorders. 18)Dementia or clinically significant mental/neurological disorders. 20)Investigator's judgement.
Target sample size	50

Research contact person
Name of lead principal investigator	Mishima Hideyuki
Organization	Aichi Medical University
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	Chigusa Abe
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Division name	Data Center
Address	21-7 Shogoinn Sakyo-ku, Kyoto
TEL	075-762-1227
Homepage URL
Email	chigusa.abe@ecrin.or.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

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 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 01 Day
Anticipated trial start date	2010 Year 09 Month 15 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
Other related information

Management information
Registered date	2010 Year 09 Month 28 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=R000005032