UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008370