UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007409
Receipt number R000006943
Scientific Title Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Date of disclosure of the study information 2012/03/01
Last modified on 2017/03/09 15:21:41

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Basic information

Public title

Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer

Acronym

Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer

Scientific Title

Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer

Scientific Title:Acronym

Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer

Region

Japan


Condition

Condition

advanced and/or recurrent gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility of S-1+CDDP chemotherapy with short hydration

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Safety

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

Medicine

Interventions/Control_1

S-1 is orally administered for 21 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 8 .

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)Histologically proven adenocarcinoma of advanced gastric cancer(included esophagogastric junction)
2)CDDP-na&iuml;ve patients
3)ECOG Performance status(PS) of 0-1.
4)Age of 20 years or older.
5 ) Life expectancy is less than 3 months
6)no severe organ failure
7) possible to oral intake
8) written informed consent

Key exclusion criteria

(1) Patient with administration contraindication of S-1 or CDDP
(2,3,4,5) pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, ileus, uncontrollable diabetes, hypertension, renal failure, hepatic cirrhosis, active interstitial.
(6) Symptomatic pleural effusion or ascites
(7) metastasis to the brain
(8) Watery diarrhea
(9) Symptomatic psychological disease
(10)Concomitant therapy with flucytocine or phenytoin
(11)Pregnancy or breast feeding
(12)Decision as ineligible by principal investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshio Naomoto

Organization

Kawasaki Medical School

Division name

Department of General Surgery

Zip code


Address

2-6-1, Nakasange, Kita-Ward, Okayama-City, Okayama-Prefecture

TEL

086-225-2111

Email

ynaomoto@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoki Yamatsuji

Organization

Kawasaki Medical School

Division name

Department of General Surgery

Zip code


Address

2-6-1 Nakasange, Kita-ku, Okayama City, Okayama, 700-8505, Japan

TEL

086-225-2111

Homepage URL


Email

yama-t@med.kawasaki-m.ac.jp


Sponsor or person

Institute

NPO Japan Southwest Oncology Research Support Organization (JSWOG)

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



Other administrative information

Date of disclosure of the study information

2012 Year 03 Month 01 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

No longer recruiting

Date of protocol fixation

2011 Year 06 Month 29 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 02 Month 29 Day

Last modified on

2017 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006943


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name