UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001119
Receipt number R000001358
Scientific Title Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)
Date of disclosure of the study information 2008/04/14
Last modified on 2012/04/13 15:36:39

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Basic information

Public title

Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)

Acronym

Phase II study of DCS for advanced gastric cancer

Scientific Title

Phase II study of the combination of docetaxel, cisplatin plus S-1(DCS) for advanced or recurrent gastric cancer(KDOG 0601)

Scientific Title:Acronym

Phase II study of DCS for advanced gastric cancer

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To examine the efficacy and safety of combination chemothrapy with Docetaxel, cisplatin and S-1 in advanced or recurrent gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

efficacy

Key secondary outcomes

Adverse events,PFS,MST,TTP


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 80 mg/m2 PO BID days 1-14
Docetaxel 40 mg/m2 DIV day 1
Cisplatin 60 mg/m2 DIV day 1
every 28 days

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) Histologically confirmed gastric adenocarcinoma
2) Measurable disease by Response Evaluation Criteria in Solid Tumors Group (RECIST)
3) No prior chemotherapy or radiation therapy for gastric cancer
4) Age between 20 and 80 years
5) Adequate organ function
1. WBC >=3,000/mm3,
2. platelets >=100,000/mm3
3. T-Bil <=1.5 mg/dL
4. GOT, GPT <=100 U/L
5. Cr <=1.5 mg/dL
6. creatinine clearance >50ml/min
7. normal ECG
6) ECOG performance status (PS) of 0 to 2
7) Oral food intake possible
8) A life expectancy of at least 8 weeks
9) Written informed

Key exclusion criteria

1)Patients contraindicated to docetaxel,cisplatin,S-1
2)Active infection
3)Severe heart disease
4)Uncontrolled medical conditions (paralytic ileus,bowel obstruciton,interstitial pneumonia,pulmonary fibrosis,uncontrollable diabetes mellitus,renal failure,liver cirrhosis)
5)Massive abdominal effusion or massive pleural effusion
6)Extensive bone metastasis
7)Symptomatic brain metastasis
8)Severe diarrhea
9)Severe mental disorder
10)Histroy of other active malignancy
11)Pregnancy, the desire to preserve
12)Inadequate physical condition, as diagnosed by primary physician

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Wasaburo Koizumi

Organization

Kitasato University East Hospital

Division name

Department of Gastroenterology

Zip code


Address

2-2-1, Asamizodai, Sagamihara

TEL

042-748-9111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Norisuke Nakayama

Organization

Kanagawa Cancer Center

Division name

Division of Gastroenterology

Zip code


Address

1-1-2, Nakao, Asahi-ku, Yokohama

TEL

045-391-5761

Homepage URL


Email

norisuke@kcch.jp


Sponsor or person

Institute

Department of Gastroenterology, Kitasato University School of Medicine

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

Kanagawa Cancer Center
Kitasato university Hospital

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

2008 Year 04 Month 14 Day


Related information

URL releasing protocol


Publication of results

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

Completed

Date of protocol fixation

2006 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2006 Year 10 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

Other related information



Management information

Registered date

2008 Year 04 Month 13 Day

Last modified on

2012 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001358


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name