UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003728
Receipt number R000004513
Scientific Title Phase I study of epitope peptides with UFT/UZEL for unresectable colorectal cancer
Date of disclosure of the study information 2010/06/09
Last modified on 2012/12/08 09:57:43

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Basic information

Public title

Phase I study of epitope peptides with UFT/UZEL for unresectable colorectal cancer

Acronym

Phase I study of epitope peptides with UFT/UZEL for unresectable colorectal cancer

Scientific Title

Phase I study of epitope peptides with UFT/UZEL for unresectable colorectal cancer

Scientific Title:Acronym

Phase I study of epitope peptides with UFT/UZEL for unresectable colorectal cancer

Region

Japan


Condition

Condition

unresectable colorectal cancer

Classification by specialty

Gastroenterology Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

safety

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

safety

Key secondary outcomes

immunological response
efficacy


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 Vaccine

Interventions/Control_1

Vaccination using epitope peptide from RNF43 and TOMM34

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Performance status 0-2
HLA-A24
Good function of critical organs
Written informed consents
etc,

Key exclusion criteria

1.Plegnant
2. Breastfeeding
3. Wish for pregnancy
4. Active infection
5. Steroid or immunosuppressive therapy
6. Multiple cancer
7. Doctors opinion

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyotaka Okuno

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code


Address

377-2 Ohnohigashi, Osakasayama, Osaka 589- 8511, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Fumiaki Sugiura

Organization

Kinki University School of Medicine

Division name

Department of Surgery

Zip code


Address

377-2 Ohnohigashi, Osakasayama, Osaka 589- 8511, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Kinki University School of Medicine
Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

NEDO

Organization

Division

Category of Funding Organization

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 06 Month 09 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

No longer recruiting

Date of protocol fixation

2006 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date

2012 Year 12 Month 08 Day

Date of closure to data entry

2012 Year 12 Month 08 Day

Date trial data considered complete

2012 Year 12 Month 08 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 06 Month 08 Day

Last modified on

2012 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004513


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name