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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007185
Receipt No. 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 2012/01/30

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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
Email

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
Email

Sponsor
Institute Fujita Health University
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Prospective observational study

Management information
Registered date
2012 Year 02 Month 01 Day
Last modified on
2012 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008370

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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