UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002685
Receipt number R000003278
Scientific Title Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients
Date of disclosure of the study information 2009/10/29
Last modified on 2010/05/04 17:49:41

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Basic information

Public title

Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients

Acronym

Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients

Scientific Title

Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients

Scientific Title:Acronym

Feasibility study of outpatient chemotherapy with S-1+CDDP in gastric cancer patients

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility of outpatient chemotherapy with S-1+CDDP in patients with unresectablly advanced, recurrent gastric cancer or advanced gastric cancer patients who require neoadjuvant chemotherapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Completion proportion of 2 cycles in outpatient arm

Key secondary outcomes

Completion proportion of 2 cycles in inpatient arm, completion proportion of 2 cycles in all patients, progression free survival, proportion of incidence of adverse events in outpatient arm, inpatient arm, and all patients


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1+CDDP therapy (S-1 80-120 mg day 1-21, CDDP 60 mg/m2 day 8) was repeated until the completion of 2 cycles every 5 weeks in unresectablly advanced, recurrent gastric cancer, and every 4 weeks in advanced gastric cancer patients who require neoadjuvant chemotherapy.
Recruited patients take oral hydration test over days 1-7 of the 1st cycle, and are allocated to outpatient arm when oral hydration is adequate, or to inpatient arm when inadequate.
In outpatient arm, patients are administered intravenous hydration only on day 8, and are encouraged to take oral hydration >=1.5 L on days 9-10 of each cycle, and they take antiemetics orally on days 9-11, and they also take diuretics orally as needed.

Interventions/Control_2

In inpatient arm, patients are administered intravenous hydration on days 8-10 of each cycle.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Unresectablly advanced, recurrent gastric cancer patients or advanced gastric cancer who require neoadjuvant chemotherapy.
2) Histologically confirmed primary gastric cancer.
3) Performance status (ECOG) of 0, 1, or 2.
4) Age between 20 and 75 years.
5) Estimated to be able to take oral hydration >=1.5L/day.
6) Adequate organ function confirmed by laboratory data below (within 2 weeks before registration).
Neutrophil >=1200/mcl
Hb >=8.0g/dl
Plt >=75000/mcl
T-Bil <=3.0mg/dl
GOT <=100IU/l
GPT <=100IU/l
Cr <=1.5mg/dl or estimated Ccr >=50ml/min
7) Written informed consent.

Key exclusion criteria

1) History of hypersensitivity to S-1 or CDDP.
2) Receiving fluoropyrimidine preparation.
3) Receiving systemic steroid therapy.
4) Required to continue to take flucytosine, phenytoin, and warfarin.
5) Severe complications (ileus, bowel obstruction, interstitial lung disease, uncontrolled diabetes, severe arrhythmia, heart failure, renal failure, liver cirrhosis, active hepatitis, and so on).
6) Active ischemic heart disease.
7) Woman who are pregnant, lactating, or willing to get pregnant, or man who are willing to have unprotected intercourse.
8) Severe mental disorder.
9) Regarded as inadequate physical conditions by attending physician.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takako Nakajima

Organization

National Cancer Center Hospital

Division name

Gastrointestinal Oncology Division

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

TEL

03-3541-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Okazaki

Organization

National Cancer Center Hospital

Division name

Gastrointestinal Oncology Division

Zip code


Address

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

TEL

03-3542-2511

Homepage URL


Email

sokazaki@ncc.go.jp


Sponsor or person

Institute

National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Aichi Cancer Center 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

国立がんセンター中央病院(東京都)、愛知県がんセンター中央病院(愛知県)


Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 29 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

Completed

Date of protocol fixation

2008 Year 10 Month 10 Day

Date of IRB


Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2010 Year 03 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

2009 Year 10 Month 29 Day

Last modified on

2010 Year 05 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003278


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name