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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003381
Receipt No. R000004106
Scientific Title A feasibility study of adjuvant therapy with UFT/LV plus oxaliplatin following curative resection for stage III colorectal cancer
Date of disclosure of the study information 2010/04/01
Last modified on 2014/06/04

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Basic information
Public title A feasibility study of adjuvant therapy with UFT/LV plus oxaliplatin
following curative resection for stage III colorectal cancer
Acronym A feasibility study of adjuvant therapy with TEGAFOX following curative
resection for stage III colorectal cancer
Scientific Title A feasibility study of adjuvant therapy with UFT/LV plus oxaliplatin
following curative resection for stage III colorectal cancer
Scientific Title:Acronym A feasibility study of adjuvant therapy with TEGAFOX following curative
resection for stage III colorectal cancer
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the feasibilitiy, efficacy and safety of adjuvant treatment with a combination of UFT/LV plus oxaliplatin following curative resection of stage III colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Patients ratio with completion of adjuvant TEGAFOX therapy
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 UFT 300mg per m2 per day and LV 75mg per day for 28 days
Oxaliplatin:85mg/m2 day1,15
every 5-weeks for 3-cycle
After this therapy, followed by UFT/LV until 1 year
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)Histologically proved
Adenocarcinoma of colon or rectum.
2) Stage IIIA/IIIB of colon or rectum
3)>=D2 lymph node dissection
4)Pathological curability is A or B
5)Age:20-80 years old
6)Performance status 0-1
7)Without prior anti-tumor therapy
8)Adequate organ function
9)Able to start between 8 weeks after surgery
10)The case can eat
11)Written IC
Key exclusion criteria 1)Multiple malignancies within five years
2) Other severe complications, such as pulmonary emphysema, pulmonary fibrosis, hyper pulmonary
emphysema,paralysis intestinal, intestinal obstruction, uncontrolable diabetes, cirrhosis, uncontrollable hypertension, myocardial infarction within six months, angina.
3)Diarrhea
4) Pregnant
5)Evidence of psychiatric disability interfering with enrollment to clinical trial
6)Patients judged inappropriate for this study by physicians
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Koike
Organization Toho University School of Medicine
Division name Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL 03-3762-4151
Email jkoike18@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Koike
Organization Toho University School of Medicine
Division name Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL 03-3762-4151
Homepage URL
Email jkoike18@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine
Institute
Department

Funding Source
Organization Toho University School of Medicine
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 04 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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2010 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

Management information
Registered date
2010 Year 03 Month 25 Day
Last modified on
2014 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004106

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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