UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007556
Receipt number R000008872
Scientific Title A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer
Date of disclosure of the study information 2012/03/23
Last modified on 2014/09/23 17:49:03

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Basic information

Public title

A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer

Acronym

GSL-1

Scientific Title

A phase 1 study of combination therapy with gemcitabine S-1 and leucovorin in patients with pancreatic cancer

Scientific Title:Acronym

GSL-1

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We will investigate the safety of combination therapy with gemcitabine and S-1 and leucovorin and determine the maximum tolerated dose and the recommended dose.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

Dose limiting toxicity, maximum tolerated dose, recommended dose

Key secondary outcomes

Response rate, disease control rate, progression free survival, overall survival, 1-year survival rate, feasibility, safety


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

a combination therapy with gemcitabine, S-1 and leucovorin

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

1) Patients with unresectable pancreatic cancer without prior treatment
2) Patients with pathologically proven pancreatic cancer
3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2
4) Patients of age >= 20 years
5) Patients who can eat
6) Patients have an adequate organ function defined as white cell count < 10,000/mm3, neutophils >=1,500/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal
7) Estimated survival > 2months
8) Written informed consent is required from all patients.

Key exclusion criteria

1) Patients with systolic blood pressure < 100mmHg
2) Patients with an active concomitant infection
3) Patients with digestive ulcer or gastrointestinal bleeding, severe heart or renal disease
4) Patients with an active pulmonary fibrosis or interstitial pneumonia
5) Patients with severe diarrhea
6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
7) Patients with uncontrollable massive pleural effusion or massive ascites
8) Patients with an active concomitant malignancy
9) Inappropriate patients for entry on this study in the judgement of the investigator

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Isayama

Organization

The University of Tokyo

Division name

Gastroenterology

Zip code


Address

7-3-1, Hongo Bunkyo-ku Tokyo

TEL

03-3815-5411

Email

isayama-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yousuke Nakai

Organization

University of Tokyo

Division name

Gastroenterology

Zip code


Address

7-3-1 Hongo Bunkyo-ku Tokyo

TEL

03-3815-5411

Homepage URL


Email

ynakai-tky@umin.ac.jp


Sponsor or person

Institute

The University of Tokyo, Department of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

None

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

東京大学医学部附属病院(東京都)


Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25143299

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

Main results already published

Date of protocol fixation

2012 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 03 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

2012 Year 03 Month 23 Day

Last modified on

2014 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008872


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name