UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004734
Receipt number R000005633
Scientific Title Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer
Date of disclosure of the study information 2010/12/20
Last modified on 2015/04/21 08:38:44

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Basic information

Public title

Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer

Acronym

Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP

Scientific Title

Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer

Scientific Title:Acronym

Phase I/II trial of adjuvant chemotherapy of S-1 with CDDP

Region

Japan


Condition

Condition

Stage III gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Primary objective is to estimate the maximum tolerated dose (MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP for Stage III gastric cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

estimate the maximum tolerated dose(MTD) and recommended dose (RD) of adjuvant chemotherapy of S-1 with CDDP

Key secondary outcomes

Adverse events


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 second course, S-1 with CDDP adjuvant chemotherapy is conducted. S-1 is orally administered for 28 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 1 and 15.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) confirmed gastric cancer by endscopic biopsy
2) >=D2 lymph node dissection, R0 resection
3) Stage III
4) with no distant metastasis, liver metastasis, peritoneal metastasis and negative peritoneal cytology
5) age: >=20 and <80
6) possible to oral intake
7) No prior treatment except to surgery
8) sufficient function of important organs
9) written informed consent

Key exclusion criteria

1) with serious complications (intestinal paralysis, ileus, interstitial pneumonia or pulmonary fibrosis, heart failure, kidney failure, liver failure etc)
with history of severe drug allergy
2) with clinically important infection
3) with diarrhea
4) with gastrointestinal bleeding need to repeat blood transfusion
5) with hepatocirrhosis or icterus
6) with clinically important mental disorder need to treat
7) with clinically important heart disease need to treat (ischemic heart disease, cardiac dysrhythmia etc)
8) with uncontrollable diabetes mellitus
9) pregnant or nursing women or women who like be pregnant and willing to get pregnant
10) doctor's decision not to be registered to this study

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsunehiro Takahashi

Organization

School of Medicine, Keio University

Division name

Departent of Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Tsunehiro Takahashi

Organization

School of Medicine, Keio University

Division name

Departent of Surgery

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

School of Medicine, Keio University

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


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

2010 Year 12 Month 20 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

2010 Year 04 Month 22 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 01 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

2010 Year 12 Month 16 Day

Last modified on

2015 Year 04 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005633


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name