UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasibility study of adjuvant therapy with capecitabine plus oxaliplatin (XELOX) for the patient with advanced colorectal cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Daisuke Sakai
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Team for colorectal cancer
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL
Email

Public contact
Name of contact person	Daisuke Sakai
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/25743138
Results
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