UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013479
Receipt number R000015737
Scientific Title A feasibility study of adjuvant S-1+CDDP for stage III gastric cancer
Date of disclosure of the study information 2014/03/24
Last modified on 2019/03/25 09:21:46

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Basic information

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

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


Objectives

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


Assessment

Primary outcomes

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

Key secondary outcomes



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 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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Department of Medical Oncology, Toranomon Hospitalnasoi

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toranomon Hospital IRB

Address

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

Tel

0335881111

Email

chiken-jim@toranomon.gr.jp


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

2014 Year 03 Month 24 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name