UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003751
Receipt number R000004546
Scientific Title A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.
Date of disclosure of the study information 2010/06/30
Last modified on 2010/06/14 19:13:09

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Basic information

Public title

A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.

Acronym

A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.

Scientific Title

A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.

Scientific Title:Acronym

A phase II feasibility trial of Gemcitabine Hydrochloride and Krestin combination therapy in pancreatic cancer after surgery.

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Gemcitabine Hydrochloride and Krestin combination therapy in stage III or IVa pancreatic cancer after surgery as a feasibility trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Disease-free survival

Key secondary outcomes

1) Overall survival
2) Incidence of adverse event


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

Gemcitabine Hydrochloride
1000 mg/m2 as Gemcitabine by drip infusion for 30 minutes
Once a week for 3 weeks
One course takes 4 weeks
Maximum 6 courses
Krestin
3 g per day
3 times per day
Daily oral administration
Start at initial administration of Gemcitabine Hydrochloride

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)Patients with invasive ductal pancreatic cancer.
2)Patients with resection of the primary lesion and final findings stage III or IVa.
3)Patients who is between 20 and 80 years old at the time of enrollment.
4)Patients with ECOG Performance Status Scale of 0 or 1.
5)Patients without receiving chemotherapy, radiation therapy and immunotherapy including the treatment for the other carcinoma.
6)Patients who can take medicine orally.
7)Patients who maintain function of main organ in clinical test within 14 days before enrollment.
8)Patients with starting the immunochemotherapy within 2 weeks after enrollment.
9)Patients who have given consent to participate in this clinical study.

Key exclusion criteria

1) Active double cancer.
2) Patients with severe myelosuppression.
3) Patients who receiving radiation therapy to the chest.
4) Patients with severe infection.
5) Patients with pulmonary fibrosis or interstitial lung disease.
6) Pregnant patients.
7) Patients with insanity or psychological symptom.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Uemoto

Organization

Kyoto University Hospital

Division name

Department of Hepato-Pancreatic Surgery & Transplantation

Zip code


Address

54 Kawara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, JAPAN

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kyoichi Takaori

Organization

Kyoto University Hospital

Division name

Department of Hepato-Pancreatic Surgery & Transplantation

Zip code


Address

54 Kawara-cho, Shogoin, Sakyo-ku Kyoto 606-8507, JAPAN

TEL


Homepage URL


Email

takaori@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

京都大学医学部附属病院(京都府)
京都警察病院(京都府)


Other administrative information

Date of disclosure of the study information

2010 Year 06 Month 30 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

Preinitiation

Date of protocol fixation

2010 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 Day

Last follow-up date

2013 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 06 Month 14 Day

Last modified on

2010 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004546


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name