UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004286 |
|---|---|
| Receipt number | 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 08:22:56 |
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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
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
chigusa.abe@ecrin.or.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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005032
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
