UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000080
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Fourth Department of Internal Medicine, Sapporo Medical University
Institute
Department

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
URL(English) https://upload.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


Contact us.