UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000103 |
|---|---|
| Receipt number | 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 14:00:39 |
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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
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
yamacho@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Cancer Therapy Development Organization (HiCTDO)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000152
