UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005600
Receipt number R000006619
Scientific Title Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer
Date of disclosure of the study information 2011/05/15
Last modified on 2016/07/20 22:10:21

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Basic information

Public title

Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer

Acronym

Feasibility study of S-1 and weekly cisplatin in patients recieved R0 resection gastric cancer.

Scientific Title

Feasibility stuydy of S-1 and weekly cisplatin in patients received R0 resection for Stage IIB and III gastric cancer

Scientific Title:Acronym

Feasibility study of S-1 and weekly cisplatin in patients recieved R0 resection gastric cancer.

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm the feasibility and safety of adjuvant treatment with a combination of S-1 plus weekly CDDP in patients with gastric cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Treatment compliance with proportion of patients receiving 4 courses of Adjuvant treatment according to protocol

Key secondary outcomes

Adverse Event, Overall survival,
Disease-free survival, and Relapse-free survival


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

At the first course of adjuvant chemotherapy, only S-1 is administered for 28 days followed by 14 days rest.
At the 2 - 4 course, S-1 plus CDDP adjuvant chemotherapy is conducted.
After 5 course, S-1 is conducted for 6 weeks until 1 year after surgery.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1) Histologically proved adenocarcinoma of stmach
2) >= D2 lymphnode dissection, curability A(R0)
3) Stage IIB/III/IIIB/IIIC (Japanese classification)
4) Age between 20 and 75
5) No prior chemotherapy or radiotherapy
6) Able to started of treatment between 8 weeks after surgery
7) ECOG performance status 0-1
8) With ability of oral intake
9) Patients have enough organ function for study treatment
Hemoglobin >9.0g.dl
WBC 3,500/mm3< <12,000/mm3
Neutrophil > 2,000/mm3
Platelets >100,000/mm3
Total bilirubin <1.5mg/dl
AST and ALT < 100IU
Ccr > 60ml/min
10) Written informed consent

Key exclusion criteria

1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2) administration contraindication to S-1 and CDDP
3) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
4) with active infection
5) with drug hypersensitivity
6) other severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, regular use of insulin or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
7) with water solubility diarrhea
8) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant
9) men with willing to get pregnant
10)Any other cases who are regarded as inadequate for study enrollment by the investigator

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Konno

Organization

Hamamatsu University School of Medicine

Division name

Second Department of Surgery

Zip code


Address

1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan

TEL

053-435-2279

Email

otam@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Manabu Otha

Organization

Hamamatsu University School of Medicine

Division name

Hamamatsu University School of Medicine

Zip code


Address

1-20-1, Handayama, Higashi-ku, Hamamatsu City 431-3192, Shizuoka Prefecture, Japan

TEL

053-435-2279

Homepage URL


Email

otam@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu Organization for Oncology Research and Education : HORE

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu Organization for Oncology Research and Education : HORE

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

浜松医科大学(静岡県)
県西部浜松医療センター(静岡県)
磐田市立総合病院(静岡県)


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 15 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

2011 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 01 Day

Last follow-up date

2018 Year 03 Month 01 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 05 Month 13 Day

Last modified on

2016 Year 07 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006619


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name