UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007185 |
|---|---|
| Receipt number | R000008370 |
| Scientific Title | Observational study of hand-foot syndrome events from XELOX therapy for metastatic colorectal cancer. |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2019/10/16 17:07:02 |
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Basic information
Public title
Observational study of hand-foot syndrome events from XELOX therapy for metastatic colorectal cancer.
Acronym
The study of metastatic colorectal cancer to investigate impact of learning effect.
Scientific Title
Observational study of hand-foot syndrome events from XELOX therapy for metastatic colorectal cancer.
Scientific Title:Acronym
The study of metastatic colorectal cancer to investigate impact of learning effect.
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect hand-foot syndrome events and to evaluate QOL from questionnaires for metastatic colorectal cancer treated with XELOX .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HFS (> grade 2) events rate for classification of Blum
Key secondary outcomes
Evaluation of QOL:
1) HADS (Hospital Anxiety and Depression Scale)
2)MAC (Mental Adjustment to Cancer)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Writen informed consent
2. Histological confirmation of colorectal cancer
3. Age: 20-80 years
4. Performance status (PS) 0-1
5. With first line treatment for metastatic colorectal canncer
6. Adequate organ function within 14 days before registration
Wbc >= 3000 (Neu >=1,500/ mm3)
Plt >= 100,000/ mm3
Hb >= 9.0g/dl
T-bil 1.5 times of normal range in each institute
AST, ALT and ALP =< 2.5xULN IU/L (5.0xULN IU/L in case of liver metastasis)
scre =< 1.5xULN mg/dl
Key exclusion criteria
1.Pleural effusion, peritoneal fluid and pericardial fluid.
2. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
3. Serious drug hypersensitivity or a history of drug allergy for Fluorouracil, leucovorin calcium or platinum agents.
4. Dihydropyrimidine Dehydrogenase Deficiency.
5. Evidence of interstinal lung disease, or pulmonary fibrosis.
6. Uncontrolled Active infection.
7. Difficulty on oral intake.
8. Other conditions not suitable for this study
9. Symptomatic brain metastasis.
10. Complication of cerebrovascular disease or symptoms within 1 year.
11. Any surgical treatments including skin open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
12. Planned surgery during this study.
13. Administering antithrombotic drug within 10 days.
14. Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDs).
15. Evidence of bleeding diathesis or coagulopathy.
16. Active gastrointestinal ulcer.
17. Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry.
18. Uncontrolled Hypertension.
19. Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Genichi Nshimura, Koutarou Maeda |
Organization
Kanazawa Red Cross Hospital,
Fujita Health University
Division name
Surgery
Zip code
Address
Minma 2-251 Kanazawa, 921-8162 Japan, Dengakugakubo 1-98 Kutsukake-cho Toyoake, 470-1192 Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Matsuoka |
Organization
Fujita Health University
Division name
Gastrointestinal Surgery
Zip code
Address
Dengakugakubo 1-98 Kutsukake-cho Toyoake, 470-1192 Japan
TEL
0562-93-9296
Homepage URL
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
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
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
| 2012 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Main results already published
Date of protocol fixation
| 2011 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Study design: Prospective observational study
Management information
Registered date
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008370
