UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000080
Receipt number R000000128
Scientific Title Phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer
Date of disclosure of the study information 2005/09/01
Last modified on 2006/03/14 12:38:56

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Basic information

Public title

Phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer

Acronym

Phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer

Scientific Title

Phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer

Scientific Title:Acronym

Phase I/II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer

Region

Japan


Condition

Condition

unresectable advanced gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Recently it has been reported that the combination of docetaxel, CDDP and 5-FU was effective in advanced gastric cancer. It has also been reported that S-1, a new oral fluorinated pyrimidine compound consisting of tegafur, 5-chloro-2, 4-dihydroxypyridine, and potassium oxonate, was significantly more effective as compared to 5-FU in advanced gastric cancer. Therefore, we conducted a phase II study of the combination of docetaxel, CDDP and S-1 in patients with unresectable advanced gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

efficacy

Key secondary outcomes

survival(PFS,MST)
toxicity


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

Treatment consisting of TS-1 (80mg/m2, day 1 - 14),CDDP (60 mg/m2, day 8) and Docetaxel (60mg/m2, day 8). This treatment was repeated more than 3 times every 3 wks.

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

Each patient was required to meet the following eligibility criteria: histologically proven gastric cancer (stage IIIb-IV); measurable metastatic lesions hopefully assessed by Response Evaluation Criteria in Solid Tumors (RECIST); no more than one prior chemotherapy regimen; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; age 20-80 years; adequate baseline bone marrow function (hemoglobin level 8.0 g/dl, white blood cell count 4000/mm3 and 12,000/mm3, neutrophil count >2000/mm3 and platelet count >100,000/mm3); adequate hepatic function (total bilirubin level <1.5 mg/dl, and aspartate aminotransferase, alanine aminotransferase<100U/l); adequate renal function (serum creatinine within the normal level, creatinine clearance >60ml/min); a life expectancy of at least 3 months; and written informed consent.

Key exclusion criteria

Exclusion criteria included: active infection; serious complications (severe heart disease, pulmonary fibrosis, interstitial pneumonitis and tendency to bleeding); neuropathy grade 2; edema grade 2 (NCI-CTC); active concomitant malignancy; symptomatic metastases of the central nervous system; history of drug hypersensitivity (including TXT,CDDP,TS-1 or G-CSF); serious diarrhea; pregnant and lactating females; females of childbearing age, unless using effective contraception; and other serious medical conditions.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuji Takayama

Organization

Sapporo Medical University, School of Medicine

Division name

Fourth Department of Internal Medicine

Zip code


Address

South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Sapporo Medical University, School of Medicine

Division name

Fourth Department of Internal Medicine

Zip code


Address

South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Fourth Department of Internal Medicine, Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Fourth Department of Internal Medicine, Sapporo Medical University

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 01 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

No longer recruiting

Date of protocol fixation

2005 Year 02 Month 23 Day

Date of IRB


Anticipated trial start date

2005 Year 03 Month 01 Day

Last follow-up date

2008 Year 02 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 08 Month 26 Day

Last modified on

2006 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000128


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name