UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004452
Receipt number R000005329
Scientific Title Phase I clinical trial of peptide vaccine with UFT/LV for advanced or recurrent colorectal cancer
Date of disclosure of the study information 2010/10/27
Last modified on 2012/10/31 15:53:56

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Basic information

Public title

Phase I clinical trial of peptide vaccine with UFT/LV for advanced or recurrent colorectal cancer

Acronym

Phase I clinical trial of peptide vaccine with UFT/LV for colorectal cancer

Scientific Title

Phase I clinical trial of peptide vaccine with UFT/LV for advanced or recurrent colorectal cancer

Scientific Title:Acronym

Phase I clinical trial of peptide vaccine with UFT/LV for colorectal cancer

Region

Japan


Condition

Condition

advanced or recurrent colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

We performed phase I clinical trial of the peptide vaccine therapy together with anticancer drug for the advanced colorectal cancer to confirm the safety of the treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We confirm the safety of the peptide vaccine against colorectal cancer patient.

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

Vaccine

Interventions/Control_1

Peptide vaccine therapy

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

Performance Status 0-1
Refractory to standard therapy

Key exclusion criteria

Pregnancy
Uncontrolled infection
Patients with serious concomitant disease

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Yamamoto

Organization

Tokyo Women's Medical University

Division name

Department of gastroenterological surgery

Zip code


Address

8-1, Kawata-cho, Shinjuku-ku, Tokyo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Women's Medical University

Division name

Department of gastroenterological surgery

Zip code


Address


TEL

03-3353-8111

Homepage URL


Email



Sponsor or person

Institute

Tokyo Women's Medical University

Institute

Department

Personal name



Funding Source

Organization

human Genome Center, Institute of Medical Science, University of Tokyo

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 10 Month 27 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2008 Year 05 Month 13 Day

Date of IRB


Anticipated trial start date

2008 Year 07 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 10 Month 26 Day

Last modified on

2012 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005329


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name