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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003164
Receipt No. R000003837
Scientific Title A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer
Date of disclosure of the study information 2010/02/11
Last modified on 2016/07/07

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Basic information
Public title A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer
Acronym A feasibility study of adjuvant XELOX therapy for the patient with advanced colorectal cancer
Scientific Title A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer
Scientific Title:Acronym A feasibility study of adjuvant XELOX therapy for the patient with advanced colorectal cancer
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 confirm the feasibilitiy and safety of adjuvant treatment with a combination of capecitabine plus oxaliplatin for the patient with colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Patients ratio with completion of adjuvant XELOX therapy
Key secondary outcomes Adverse events, severe adverse events, dose intensity, recurrence free survival, and overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adjuvant chemotherapy with capecitabine plus oxaliplatin
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) Histologically proved adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of colon or rectum.
2) Stage IIIA/IIIB (Japanese classification), or P1, or M1(LYM)
3) >=D2 lymph node dissection
4) Pathological curability is A or B
5) Age between 20 and 75 years
6) ECOG performance status 0-1
7) No prior chemotherapy or radiotherapy
8) Enough oral food and drug intake possible
9) Adequate organ function
10) Able to start between 4 and 6 weeks after surgery
11) Written informed consent
Key exclusion criteria 1) Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2) Pregnant or breast-feeding women
3) Severe mental disease
4) Systemic administration of corticosteroids
5) Continuous medication of flusitosine, fenitoin,and/or Warfarin
6) Other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
7) Myocardial infarction within the past 6 months
8) Inadequate physical condition, as diagnosed by primary physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Sakai
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Team for colorectal cancer
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sakai
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Department of Medical Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Homepage URL
Email

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
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
2010 Year 02 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25743138
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
2009 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 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

Management information
Registered date
2010 Year 02 Month 10 Day
Last modified on
2016 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003837

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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