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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000282
Receipt No. R000000352
Scientific Title Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer Step 2: low dose cisplatin given twice a week + S-1
Date of disclosure of the study information 2005/11/14
Last modified on 2010/07/16

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Basic information
Public title Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
Step 2: low dose cisplatin given twice a week + S-1
Acronym Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
(JFMC27-9902 Step2)
Scientific Title Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
Step 2: low dose cisplatin given twice a week + S-1
Scientific Title:Acronym Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer
(JFMC27-9902 Step2)
Region
Japan

Condition
Condition unresectable or recurrent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of a newly scheduled combination therapy of S-1 with twice a week administration of low-dose cisplatin in patients with unresectable or recurrent gastric cancer, to determine the recommended dose (RD) and MTD, and to examine the efficacy of the treatment regimen at the RD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes adverse events, anti-tumor effect
Key secondary outcomes pharmacokinetics of cisplatin,
overall survival

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 S-1 is administered orally at the dose of 40mg/m2 twice a day for 28 days, followed by 14 days rest.
Cisplatin is administered intravenously twice a week for 4 weeks, followed by 2 weeks rest.
The doses of cisplatin
1)7.5mg/m2/day x 2/week
2)10mg/m2/day x 2/week
3)15mg/m2/day x 2/week
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) Histologically or cytologically demonstrated unresectable or recurrent gastric cancer

2) With measurable or assessable legion(s)

3) Without prior anti-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible.

4) Adequate bone marrow, hepatic and renal function
(1)Hb >= 9.0 g/dl
(2)WBC 4,000 - 12,000/mm3
(3)neutrophils >= 2,000/mm3
(4)platelets >= 100,000/ mm3
(5)T-Bil <= 1.5mg/dl
(6)GOT, GPT <= 2.5 times of normal upper limits
(7)Al-p <= 2 times of normal upper limits
(8)BUN <= normal upper limits
(9)Cr<= normal upper limits
(10)CCr >= 50ml/min

5) ECOG performance status (PS) 0 to 1

6) Life expectancy longer than 3 months

7) Oral intake is possible

8) Written informed consent
Key exclusion criteria 1) severe complication(s)
2) symptomatic brain metastases
3) active double cancers
4) women who are currently pregnant, nursing, or plan to become pregnant
5) cases where the investigator disapproved of participation
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosei Hirakawa
Organization Osaka City University Graduate School of Medicine
Division name Department of Surgical Oncology
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL 06-6645-3838
Email

Public contact
Name of contact person
1st name
Middle name
Last name Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name Office
Zip code
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL 03-5627-7594
Homepage URL http://www.jfmc.or.jp/
Email jfmc-dc@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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 11 Month 14 Day

Related information
URL releasing protocol
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
2003 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2003 Year 12 Month 01 Day
Last follow-up date
2009 Year 09 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 11 Month 14 Day
Last modified on
2010 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000352

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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