UMIN-CTR Clinical Trial

Public title

A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer

Acronym

Adjuvant S-1+CDDP for stage III gastric cancer

Scientific Title

A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer

Scientific Title:Acronym

Adjuvant S-1+CDDP for stage III gastric cancer

Region

Japan

Condition

Stage III (the 14th edition of staging system of Japanese Classification of Gastric Carcinoma) gastric cancer based on pathological findings after curative resection.

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study will evaluate the feasibility of TS-1 and cisplatin for patients of stage III gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The proportion of accomplishing three cycles S-1+CDDP therapy

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1 and cisplatin

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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with histologically proved adenocarcinoma of advanced gastric cancer and esophagogastric junction.
2) Patients after curative resection of gastric cancer, and was diagnosed stage III (14th staging system of Japanese Gastric Cancer Association).
3) Age: 20-75.
4) ECOG performance status 0-1.
5) Patients with adequate bone marrow reserve (neutrophil count >=1500/mm3, hemoglobin level >= 8.0 g/dL, platelet count >= 100,000/mm3), adequate liver function (AST and ALT <= 100 IU/L, total bilirubin <= 1.5 mg/dL), kidney function (serum creatinine <=1.5 mg/dL).
6) Patients who can intake orally.
7) Written informed consent obtained from patients.

Key exclusion criteria

1) Patients who received surgery within 2 weeks before enrollment.
2) Patients with uncontrable diabetis.
3) Patients who has past history of myocardial infarction within 6 months before enrollment or who has unstable angina.
4) Patients who receive anti-arrhythmia drug (except warfarin for atrial fibrillation).
5) Patients with liver chirrosis.
6) Patients with severe renal failure.
7) Patients with ileus or subileus.
8) Patients who receive continuous corticosteroid administration.
9) Patients with active infections.
10) Patients with uncontrollable ascites, pleural effusion or pericardial effusion.
11) Patients with a history of serious drug allergy.
12) Patients with grade 2-4 diarrhea based on CTCAE ver 4.
13) Patients with interstitial pneumonia or pulmonary fibrosis detected by chest X-ray. Pregnant or lactating female.
14) Patients with grade 2-4 neuropathy based on CTCAE ver 4.
15) Patients who recieved transfusion within 2 weeks before enrollment, or has active bleeding.
16) Pregnant or lactating female.
17) Other patients evaluated to be inadequate to participate in this study by investigators.

Target sample size

30

Name of lead principal investigator

1st name	Koichi
Middle name
Last name	Suyama

Organization

Toranomon Hospital

Division name

Department of Medical Oncology

Zip code

105-8470

Address

2-2-2 Toranomon, Minato-ku, Tokyo,JAPAN

TEL

0335881111

Email

kou_susan@yahoo.co.jp

Name of contact person

1st name	Koichi
Middle name
Last name	Suyama

Organization

Toranomon Hospital

Division name

Department of Medical Oncology

Zip code

105/8470

Address

2-2-2 Toranomon, Minato-ku, Tokyo,JAPAN

TEL

0335881111

Homepage URL

Email

kou_susan@yahoo.co.jp

Institute

Department of Medical Oncology, Toranomon Hospitalnasoi

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Toranomon Hospital IRB

Address

2-2-2, Toranomon,Minato-ku, Tokyo, Japan

Tel

0335881111

Email

chiken-jim@toranomon.gr.jp

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

2014

Year

03

Month

24

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

Open public recruiting

Date of protocol fixation

2014

Year

03

Month

17

Day

Date of IRB

Anticipated trial start date

2014

Year

03

Month

24

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

03

Month

21

Day

Last modified on

2019

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015737