UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008814 |
|---|---|
| Receipt number | R000010097 |
| Scientific Title | Efficacy of celecoxib for prevention of oxaliplatin related injection pain in patients with stage II/III colon cancer: a randomized phase II trial |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2021/05/11 16:48:05 |
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Basic information
Public title
Efficacy of celecoxib for prevention of oxaliplatin related injection pain in patients with stage II/III colon cancer: a randomized phase II trial
Acronym
COX study
Scientific Title
Efficacy of celecoxib for prevention of oxaliplatin related injection pain in patients with stage II/III colon cancer: a randomized phase II trial
Scientific Title:Acronym
COX study
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of celecoxib for prevention of oxaliplatin related injection pain in patient with stage II/III colon cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
incidence of at least grade 2 injection pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of the celecoxib
Interventions/Control_2
no treatment
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically confirmed colon cancer
(2) Histological stage II orIII colon cancer or rectosigmoid cancer resected with D2 or more lymph node dissection
(3) Able to start protocol treatment within 10 weeks of surgical procedure
(4) Age<80 years old
(5) Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1
(6) No prior chemotherapy or radiotherapy for target disease
(7) Preservation of primary organ function
white blood cell(WBC)count> 3,000/mm3 and <12,000/mm3, neutrophil count>1,500/mm3, haemoglobin >8.0 g/dl, platelet count>100,000/mm3, aspartate aminotransferase, alanine aminotransferase (ALT) <100 IU/L, serum total bilirubin <1.5 mg/dl, serum creatinine <1.5 mg/dl
(8) After basic screening, informed consent to participate in the study was obtained from patients
Key exclusion criteria
(1) History of severe hypersensitivity including aspirin-induced asthma
(2) Severe dysesthesia including functional disorder
(3) Cardiovascular risk factor (including history of poorly controlled hypertension, unstable angina, myocardial infarction or brain infarction. NYHA III or IV cardiac failure.)
(4) History of gastrointestinal ulcer including perforation or intestinal bleeding
(5)Disease-free less than 5 years
(6) Concurrent infectious disease
(7) Serious concurrent mental disease
(8) Uncontrollable sever concurrent disease
(9) Having analgesic drugs (excluding low dose aspirin <100mg per day)
(10) Pregnant or lactating, or planning to become pregnant
(11) Judged to be unsuitable for participation in the clinical study by the investigator for any other reason
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuyoshi |
| Middle name | |
| Last name | Ota |
Organization
Yokohama City University
Division name
Gastroenterological surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
0457872650
m.ota771@gmail.com
Public contact
Name of contact person
| 1st name | Mitsuyoshi |
| Middle name | |
| Last name | Ota |
Organization
Yokohama City University
Division name
Gastroenterological surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, KANAGAWA
TEL
0457872650
Homepage URL
aishibe@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University , Gastroenterological surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City, KANAGAWA
Tel
045-370-7627
rinri@yokohama-cu.ac.jp
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
| 2012 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/30523381/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/30523381/
Number of participants that the trial has enrolled
81
Results
81 patients were recruited to this study and randomly divided into 2 groups: 38 patients in the C- group and 39 patients in the C+ group. Four cases were excluded at the analysis stage because they had not received the allocated intervention. The rate of grade 2 or more vascular pain was 55.3% in the C- group and 53.8% in the C+ group (p=1.000).
Celecoxib was unable to prevent oxaliplatin-related vascular pain in this study.
Results date posted
| 2021 | Year | 05 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 64.1 years in the
C- group and 65.1 years in the C+ group, and there were 24 and 26 men in each group, respectively. Stage II and III colon cancer were noted 16 (19.5%) and 61 (80.5%) patients in the C+ and C- groups, respectively. The difference in the patient characteristics between the two groups was not
significant.
Participant flow
The patients in　the C+ group took celecoxib as a premedication 2 h before starting oxaliplatin twice a day (400 mg/day)on days 1-21
Adverse events
The rate of grade 2 or more vascular pain was 55.3% in the C-group and 53.8% in the C+ group (p=1.000)
Outcome measures
The rate of grade 2or more vascular pain was 55.3% in the C- group and 53.8% in the C+ group (p=1.000)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010097
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| Registered date | File name |
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