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
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
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
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
