UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016973
Receipt number R000019672
Scientific Title Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer
Date of disclosure of the study information 2015/03/31
Last modified on 2016/09/30 12:00:52

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Basic information

Public title

Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer

Acronym

G-SOX(130) P-II

Scientific Title

Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer

Scientific Title:Acronym

G-SOX(130) P-II

Region

Japan


Condition

Condition

Advanced gastric cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility, safety and efficacy of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

The proportion of patients who recieved at least 80% of the planned dose for the first three cycles

Key secondary outcomes

Response rate, progression-free survival, overall survival, treatment discontinuation due to adverse events, and relative dose intensity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

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 plus oxaliplatin (130 mg/m2, every
3 weeks)

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 confirmed gastric adenocarcinoma
2) Unresectable advanced or recurrent gastric cancer
3) Adequate oral intake
4) Measurable or non-measurable disease
5) Age >= 20 years
6) Eastern Cooperative Oncology Group Performance status 0 or 1
7) HER-2 negative, or unknown at registration
8) No prior chemotherapy, immunotherapy or radiation therapy for advanced disease
9) Adequate organ function
10) Written informed consent

Key exclusion criteria

1) Massive ascites
2) Massive pleural effusion
3) Evidence of central nervous system metastasis, or clinically suspected
4) Poorly controlled diabetes mellitus
5) Serious lung or cardiovascular disease
6) Active concomitant malignancy
7) Active infection
8) Diarrhea
9) Peripheral neuropathy
10) Blood transfusion, blood products or G-CSF within 21 days at registration
11) Pregnant, nursing or unwilling to practice contraception during the study
12) Severe mental illness

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nozomu Machida

Organization

Shizuoka Cancer Center

Division name

Division of Gastrointestinal Oncology

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan

TEL

055-989-5222

Email

no.machida@scchr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yosuke Kito

Organization

Shizuoka Cancer Center

Division name

Division of Gastrointestinal Oncology

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan

TEL

055-989-5222

Homepage URL


Email

y.kito@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Shizuoka Cancer Center

Organization

Division

Category of Funding Organization

Local Government

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

2015 Year 03 Month 31 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

2015 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 31 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

2015 Year 03 Month 30 Day

Last modified on

2016 Year 09 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019672


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name