UMIN-CTR Clinical Trial

Public title

A phase ll study of TS-1+L-OHP(SOX) therapy for Her2-negative advanced/metastatic gastric cancer with measurable lesions (OGSG1405)

Acronym

SOX therapy for Her2-negative gastric cancer (OGSG1405)

Scientific Title

A phase ll study of TS-1+L-OHP(SOX) therapy for Her2-negative advanced/metastatic gastric cancer with measurable lesions (OGSG1405)

Scientific Title:Acronym

SOX therapy for Her2-negative gastric cancer (OGSG1405)

Region

Japan

Condition

Gastric carcinoma

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To confirm the efficacy and safety of TS-1+L-OHP (SOX) therapy for Her2-negative advanced/matastatic gastric cancer with measurable lesions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Response rate (RR)

Key secondary outcomes

Overall survival (OS)
Progression free survival (PFS)
Time to Treatment Failure (TTF)
Incidence of adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1: 80mg/m2 twice a day oral intake on days 1-14 followed by 7 days rest.
L-OHP: 130mg/m2 div. on day 1.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) histologically proven advanced/recurrent gastric adenocarcinoma with Her2-nagative or unknown
2) with measurable lesions by RECIST version 1.1
3) 20 years of age and older
4) Performance Status by Eastern Cooperative Oncology Group of 0 or 1
5) without any history of chemotherapy or radiation therapy and for recurrent cases, with longer than 6 months rest of adjuvant chemotherapy
6) with good functions of important organs by a data taken within 2 weeks at registration
1. Neutrophil: =>1,500/mm3
2.Platelet: =>100,000/mm3
3. Hemoglobin: =>8.0 g/dL
4. T.bil.: =<2.0 mg/dL
5. AST(GOT): =< 100 IU/L
(=<200 IU/L in patients with
liver metastasis)
6. ALT(GPT): =< 100 IU/L
(=<200 IU/L in patients with
liver metastasis)
7.SCr: =<1.5mg/dL
8. cleatinine clearance : =>50mL/min
* CC by Cockcroft-Gault method is available
7) with an expected survival longer than 3 months
8) Patients able to take orally
9) with written Informed Consent

Key exclusion criteria

1) With history of chemotherapy and/or radiation therapy
2) with active double cancers excluding carcinoma in situ and/or prior cancer cured with longer than 5 year interval
3) with symptoms due to metastasis in the central nerve
4) have a history of severe drug hypersensitivity
5) with below comorbidity;
1. uncontrolled DM
2. uncontrolled hypertension
3. liver cirrhosis, hepatic failure
4. renal failure
5. interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema
6. with active infectious diseases
7. with a history of heart failure, cardiac infarction, angina pectoris and/or abnormal electrocardiogram within 6 months
6) HBs antigen positive
7) with active bleeding
8) with sensory neuropathy
9) with severe diarrhea (over 4 times a day or watery diarrhea )
10) under medication of flucytosine phenytoin or warfarin
11) under continuous steroids medication
12) women pregnant and/or nursing or men who like to have children in future
13) patients with a psychological disease or symptoms whom physician in charge judges to be unable to participate
14) Any patients judged by the physician in charge to be unfit to participate in the study

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Masahiro Goto

Organization

Osaka Medical College

Division name

Chemotherapy Center

Zip code

Address

2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181

TEL

072-683-1221

Email

in2030@poh.osaka-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazumasa Fujitani

Organization

Osala General Medical Center

Division name

Department of surgery

Zip code

Address

3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka-City

TEL

06-6692-1201

Homepage URL

Email

fujitani@gh.opho.jp

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group

Institute

Department

Personal name

Organization

Osaka Clinical Study Supporting Organization

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

2015

Year

03

Month

31

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

Terminated

Date of protocol fixation

2015

Year

02

Month

07

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

01

Day

Last follow-up date

2019

Year

02

Month

28

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

03

Month

30

Day

Last modified on

2018

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019699