UMIN-CTR Clinical Trial

Public title

Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer

Acronym

Randomized controlled trial of gemcitabine vs gemcitabine/S-1 in advanced nonresectable pancreatic cancer(GEMSAP study)

Scientific Title

Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer

Scientific Title:Acronym

Randomized controlled trial of gemcitabine vs gemcitabine/S-1 in advanced nonresectable pancreatic cancer(GEMSAP study)

Region

Japan

Condition

Advanced nonresectable pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this trial is to evaluate gemcitabine/S-1 combination therapy compared with gemcitabine alone in advanced non-resectable pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III

Primary outcomes

Progression-free Survival
Overall Survival
Response Rate

Key secondary outcomes

Clinical Benefit Response
Tumor Marker
Adverse effects

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 40mg/m2 is administered orally twice daily from day 1 to day 14 followed by a two-week rest. Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1 and 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal or unacceptable toxicity.

Interventions/Control_2

Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal, or unacceptable toxicity.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The study is designed to enroll patients with nonresectable, pathologically proven, locally advanced or metastatic pancreatic cancer. Other eligibility criteria includes no prior therapy, performance status of 0-2, age between 20 and 79 years, life expectancy more than 3 months, and adequate organ function defined as white blood cell count >=3,000/mm3;, platelet count>=100,000/mm3;, hemoglobin>=10g/dl, total and direct bilirubin <=2 times the upper limit of normal, AST and ALT <=5 times the upper limit of nomal, and creatinine <=1.5 times the upper limit of normal, creatinine clearance>=50ml/ml. Written informed consent is required from all patients.

Key exclusion criteria

The exclusion criteria are as follows: active infection, digestive ulcer or bleeding, stomach or esophageal varices, pregnant or lactating women, women of childbearging age, active concomitant malignancy, severe drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.

Target sample size

106

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Isayama

Organization

Faculty of Medicine, University of Tokyo

Division name

Department of Gastroenterology

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

Name of contact person

1st name
Middle name
Last name	Hiroyuki Isayama

Organization

Faculty of Medicine, University of Tokyo

Division name

Department of Gastroenterology

Zip code

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL

Email

isayama-2im@h.u-tokyo.ac.jp

Institute

Faculty of Medicine, University of Tokyo

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

10

Month

05

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.nature.com/bjc/journal/v106/n12/full/bjc2012183a.html

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

Recruitment status

Main results already published

Date of protocol fixation

2006

Year

06

Month

04

Day

Date of IRB

Anticipated trial start date

2006

Year

07

Month

01

Day

Last follow-up date

2009

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2006

Year

10

Month

03

Day

Last modified on

2015

Year

12

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000593