UMIN-CTR Clinical Trial

Public title

QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-

Acronym

QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-

Scientific Title

QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-

Scientific Title:Acronym

QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer -A Pilot study-

Region

Japan

Condition

Gastric Cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

QOL measurement of Capecitabine/CDDP or S-1/CDDP in patients with Advanced Gastric Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

QOL evaluation

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Capecitabin+CDDP (XP)
Day1 to 14:Capecitabin take orally(twicw a day)
Day1 CDDP:Drip infusion
Day15 to 21:7 days rest

Interventions/Control_2

S-1+CDDP (SP)
Day1 to 21:S-1 take orally(twicw a day)
Day8:CDDP 60mg/m2 Drip infusion
Day22 to 35:14 days rest

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1)proven gastric adenocarcinoma R0 unresectable or reccurent gastric cancer
2)HER2 negative or unknown gastric cancer
3)patients between 20 and 75 years old
4)PS(ECOG) between 0 and 2
5)patients who not undergo chemotherapy and/or radiation therapy
6)with a good condition of important organs recent 14 days
1.WBC>=3,000/mm3
2.neutrophil>=1,500/mm3
3.platelet>=100,000/mm3
4.hemoglobin>=8.0g/dl
5.total bilirubin<=1.5mg/dl
6.AST(GOT)<=100IU/L (with hepatic metastasis <=150)
7.ALT(GPT)<=100IU/L (with hepatic metastasis <=150)
8.serum creatinine<=1.2mg/dl
9.creatinin clearance>=60ml/min
7)expected survival longer than 3 months
8)patients who can take orally
9)written informed consent to participate in this study

Key exclusion criteria

1)with prior chemotherapy and/or radiation therapy
2)patients administrated fluoropyrimidine before less than 6 months of the registration
3)with a history of platinum administrarion
4)simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.Carcinoma in situ or Cancers localized in membranous layer are not included to double cancer.
5)with symptoms of brain metastasis
6)with history of severe allergy against medicines
7)with following diseases
1.uncontrolled DM
2.uncontrolled high-blood pressure
3.liver cirrhosis and/or liver failure
4.renal failure
5.interstitial pneumonitis, pulmonary fibrosis, severe athelectasis
6.active infection diseases
7.heart failure, cardic infarction and/or severe disorder on ECG during recent 6 months
8)HBs positive status
9)with severe diarrhea (watery stool over 4 times a day)
10)patients who have flucytosine, fenitoin or walfarin
11)patients who have steroids continuously
12)women pregnant or women who like to be pregnant or males who like to have their own baby
13)patients decided not to register to this study due to psychologic diseases and/or psychological symptoms
14)patients whom doctor decide not ro register to this study

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Koji Nakai

Organization

Kansai Medical University

Division name

Department of surgery

Zip code

Address

10-15, Fumizono-cho, Moriguchi City, Osaka, Japan

TEL

06-6992-1001

Email

Name of contact person

1st name
Middle name
Last name	Koji Nakai

Organization

Kansai Medical University

Division name

Department of surgery

Zip code

Address

10-15, Fumizono-cho, Moriguchi City, Osaka, Japan

TEL

06-6992-1001

Homepage URL

Email

nakaik@takii.kmu.ac.jp

Institute

Kansai Medical University

Institute

Department

Personal name

Organization

Kansai Medical University

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

2012

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2012

Year

03

Month

06

Day

Date of IRB

Anticipated trial start date

2012

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

07

Month

10

Day

Last modified on

2012

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009871