UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000188
Receipt number R000000189
Scientific Title A phase I study of TS-1 and docetaxel for advanced gastric cancer
Date of disclosure of the study information 2005/09/12
Last modified on 2005/09/08 11:13:01

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Basic information

Public title

A phase I study of TS-1 and docetaxel for advanced gastric cancer

Acronym

A phase I study of TS-1 and docetaxel for advanced gastric cancer

Scientific Title

A phase I study of TS-1 and docetaxel for advanced gastric cancer

Scientific Title:Acronym

A phase I study of TS-1 and docetaxel for advanced gastric cancer

Region

Japan


Condition

Condition

advanced gastric cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To estimate the maximum tolerable dose and recommended dose of TS1 and docetaxel,and to determine the efficacy and safety of the combination of TS1 and carboplatin in patients with advanced gastric cance.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Decision of the recommended dose of TS1 and docetaxel

Key secondary outcomes

Determination of dose limited toxicity and response and safety of the combination of TS1 and docetaxel


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

TS1: 80 mg/body/day, orally 21days, every 5 weeks
Docetaxel: 15, 20, 25, or 30 mg/m2, day 1, 8, 15, every 5

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Gastric cancer
2) At least one measurable lesion
3) Inoperable or relapsed gastric cancer
4) Prior 2 regimens of chemotherapy and no prior treatment of TS1 or docetaxel
5) Age > 20 years
6) Performance status (PS) of 0 to 1
7) Adequate main organ functions
WBC > 4000/mm3,< 12000/mm3
Plt > 100000/mm3
Hb > 8.0g/dl
GOT/GPT < 2.5 x normal range
Serum creatinine < 1.5mg/dl
8) Normal ECG (NCI-CTC < Grade 1)
9) Aural ingestion
10) Estimation of at least 3 months survival
11) Written informed consent

Key exclusion criteria

1) History of active other malignancy
2) Severe heart disease (uncontrolled angina pectoris,myocardial infarction,heart failure within 3 months
3) Uncontrolled diabetes and hypertension
4) Severe complication (infection, bowel obstruction,or hemorrhage etc.)
5) > G2 neuropathy
6) Massive pleural,cardiac,or abdominal effusion
7) Intestinal fresh hemorrhage
8) Symptomatic brain metastasis
9) Pregnant women or women willing child-bearing
10) History of severe drug allergic reaction
11) Limitation of use of TS1 or docetaxel
12) Inadequate condition diagnosed by primary physician

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Tamura MD

Organization

Kinki University School of Medicine, Nara Hospital

Division name

Department of Medical Oncology

Zip code


Address

1248-1, Otoda, Ikoma, Nara, 630-0293, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kinki University School of Medicine, Nara Hospital

Division name

Department of Medical Oncology

Zip code


Address

1248-1, Otoda, Ikoma, Nara, 630-0293, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Medical Oncology,
Kinki University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Medical Oncology,
Kinki University School of Medicine

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

2005 Year 09 Month 12 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

Suspended

Date of protocol fixation

2002 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2002 Year 12 Month 01 Day

Last follow-up date

2004 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 09 Month 12 Day

Last modified on

2005 Year 09 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name