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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004286
Receipt No. R000005032
Scientific Title Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)
Date of disclosure of the study information 2010/10/01
Last modified on 2018/09/20

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Basic information
Public title Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin
through peripheral vein (APOLLO)
Acronym Randomized phase II study of adding steroid for prevention of venous pain in CRC patients who are receiving oxaliplatin through peripheral vein (APOLLO)
Scientific Title Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin
through peripheral vein (APOLLO)
Scientific Title:Acronym 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
1st name
Middle name
Last name Mishima Hideyuki
Organization Aichi Medical University
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 Chigusa Abe
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name Data Center
Zip code
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)

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 10 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 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 09 Month 01 Day
Date of IRB
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

Other
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

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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