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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004729
Receipt No. 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

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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
Institute School of Medicine, Keio University
Institute
Department

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
URL(English) https://upload.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


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