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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000103
Receipt No. R000000152
Scientific Title Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer
Date of disclosure of the study information 2005/10/01
Last modified on 2006/09/18

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Basic information
Public title Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer
Acronym Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer
Scientific Title Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer
Scientific Title:Acronym Phase II Study of Docetaxel and S-1 Combination Therapy for Advanced or Recurrent Gastric Cancer
Region
Japan

Condition
Condition Metastatic gastric cancer (Advanced or recurrent gastric cancer)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of docetaxel in combination with a novel, oral 5-fluorouracil analogue S-1 for patients with advanced or recurrent gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Tumor response rate
Key secondary outcomes 1)Adverse events,
2)Progression free-survival (PFS)
3)Median overall survival (MST)

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 Intravenous administration of 40 mg/m2 docetaxel on Day 1 and oral administration of 80 mg/m2/day S-1 on Days 1 to 14 every 3 weeks
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1)With pathologically proven gastric cancer
(2)With at least one measurable lesion (RECIST)
(3)With advanced or recurrent gastric cancer
(4)No prior chemotherapy or 1 regimen that was completed >=28 days prior to entry
(5)ECOG performance status<=2
(6)Life expectancy estimated>=12 weeks
(7)With adequate bone marrow, cardiac, respiratory, hepatic, and renal functions. Defined as: white blood cell count>=4000 mm3<=12,000 mm3, neutrophil count>=2000 mm3, hemoglobin>=9.0 g/dl, platelet>=100,000 mm3, AST and ALT within two times the upper limit of normal for the institution, serum bilirubin level<=1.5 mg/dl, BUN<=25 mg/dl, serum creatinine level<=1.5 mg/dl, creatinine clearance>=50 ml/min.
(8)age 20-75 years
(9)With written informed consent
Key exclusion criteria 1)Symptomatic infectious disease
2)Accompanied serious diseases such as pulmonary fibrosis, interstitial pneumonia, and symptomatic bleeding tendency
3)Peripheral neuropathy>=grade 2
4)Edema>=grade 2
5)Active secondary cancer
6)Symptomatic pleural effusion or ascites
7)Pregnancy or breast feeding
8)Obstructive bowel disease
9)Concomitant therapy with another anticancer drug or flucytocine
10)Past history of allergic reaction to polysorbate 80
11)A past history of drug allergy
12)A past history of allergic reaction to alcohol
13)Symptomatic psychological disease, or uncontrollable diabetes
14)Hemorrhage/bleeding>=grade 3 (NCI-CTC)
15)Decision as ineligible by principal investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Nishiyama
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Department of Translational Cancer Research
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5839
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Nishiyama
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Department of Translational Cancer Research
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5839
Homepage URL http://www.hictdo.or.jp/tiken.html
Email yamacho@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department

Funding Source
Organization Hiroshima Cancer Therapy Development Organization (HiCTDO)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hiroshima Univ., Hokkaido Univ., Fukushima Med. Univ., Hiroshima City Hosp., Hiroshima City Asa Hosp.
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 HiCTDO protocol #1
Org. issuing International ID_1 Hiroshima Cancer Therapy Development Organization (HiCTDO)
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 10 Month 01 Day

Related information
URL releasing protocol http://www.hictdo.or.jp/tiken.html
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
2002 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2002 Year 08 Month 01 Day
Last follow-up date
2006 Year 03 Month 01 Day
Date of closure to data entry
2006 Year 03 Month 01 Day
Date trial data considered complete
2006 Year 04 Month 01 Day
Date analysis concluded
2006 Year 06 Month 01 Day

Other
Other related information Interim results have been published.
(http://www.asco.org/ac/1,1003,_12-002643-00_18-0034-00_19-0031581,00.asp)
Final results have been published. (Clinical Cancer Research 2006;12(11):3402-3407

Management information
Registered date
2005 Year 09 Month 01 Day
Last modified on
2006 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000152

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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