UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004729
Receipt number R000005630
Scientific Title Phase I/II study of combination chemotherapy with Paclitaxel and TS-1 and Cisplatin for unresectable/ recurrent gastric cancer
Date of disclosure of the study information 2011/01/01
Last modified on 2015/04/21 08:39:15

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Basic information

Public title

Phase I/II study of combination chemotherapy with Paclitaxel and TS-1 and Cisplatin for unresectable/ recurrent gastric cancer

Acronym

Phase I/II study of combination chemotherapy with Paclitaxel and TS-1 and Cisplatin

Scientific Title

Phase I/II study of combination chemotherapy with Paclitaxel and TS-1 and Cisplatin for unresectable/ recurrent gastric cancer

Scientific Title:Acronym

Phase I/II study of combination chemotherapy with Paclitaxel and TS-1 and Cisplatin

Region

Japan


Condition

Condition

unresectable or recurrent gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In the phase I trial, primary objective is to estimate the maximum tolerated dose(MTD) and recommended dose(RD) of Paclitaxel and cisplatin with S-1 chemoradiotherapy for unresectable / recurrent gastric cancer.
In the phase II trial, primary objectives is to evaluate the efficacy and safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

[phase I]
Estimate the maximum tolerated dose (MTD) and recommended dose (RD) of PTX and CDDP
[phase II]
Response rate

Key secondary outcomes

[phase II]
Overall Survival, Progression Free Survival, 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

S-1, CDDP and PTX combination chemotherapy is conducted. The S-1 is administered for 14 days followed by 14 days rest according to body surface area. CDDP and PTX 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)inoperable and recurrent gastric cancer
3)have measurable tumor region (preferable that patient have the target region which matched to RECIST guideline)
4)more than 10mm of longest diameter by spiral computed tomography or more than 20mm of longest diameter by computed tomography.
5) No prior chemotherapy. Only the case who has passed six months or more since chemotherapy ended assumes is acceptable.
6) No prior radiotherapy. The case who has received radiotherapy for non target region is acceptable.
7) age: >=20 and <75
8) Performance status 0 or 1
9) Expected to survive more than 3 months
10) sufficient function of important organs
1.WBC: >=4,000/mm3 and <=12,000/mm3
2.Neu: >=2000/mm3
3.Platelet: >=100,000/mm3
4.sT.bil: 1.5mg/dl
5.AST, ALT: 2.5 times of normal range in each institute
6.Haemoglobin: >=9.0g/dL
7.Serum creati: <=1.5mg/dL
8.Ccr: >=60 ml/min/body
11) possible to oral intake
12) written informed consent

Key exclusion criteria

1) with heart disease needed to treat (ex. ischemic cardiac disease, arrhythmia)
Left ventricular hypertrophy according to high blood pressure, slight left ventricle load, slight right bundle branch block are acceptable.
2) Cardiac infarction that developed within six months
3) Cirrhosis and hepatitis of briskness
4) Breathing difficulties that require oxygen administration by interstitial pneumonia and lungs fiber syndrome, etc.
5) Gut freshness hemorrhage that repeatedly requires transfusion
6) with clinically important mental disorder need to treat or treating with mind drug
7) with uncontrollable diabetes mellitus
8) with intestinal obstruction and sub-intestinal obstruction
9) infection with fever or doubt it
10) Double cancer of briskness
11) brain metastasis with symptom
12) Acute inflammatory disorder
13) Peripheral neuropathy
14) history of severe drug anaphylaxis
15) history of severe anaphylaxis to drug included Cremohor EL or Stiffening castor oil
16) pregnant woman, breast-feeding woman, and possibility of pregnancy
17) doctor's decision not to be registered to this study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsunehiro Takahashi

Organization

School of Medicine, Keio University

Division name

Department of surgery, Department of internal medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

School of Medicine, Keio University

Division name

Department of surgery

Zip code


Address


TEL


Homepage URL


Email

tsunehiro-t@a8.keio.jp


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

2011 Year 01 Month 01 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

2009 Year 09 Month 28 Day

Date of IRB


Anticipated trial start date

2009 Year 10 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 15 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=R000005630


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name