UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003381
Receipt number 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 18:47:53

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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 or person

Institute

Toho University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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