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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000502
Receipt No. R000000606
Scientific Title Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.
Date of disclosure of the study information 2006/10/14
Last modified on 2011/10/13

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Basic information
Public title Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.
Acronym Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.
Scientific Title Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.
Scientific Title:Acronym Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.
Region
Japan

Condition
Condition Patients with metastatic or recurrent gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with advanced gastric cancer to determine the recommended dose (RD) and maximum tolerated dose (MTD). And to evaluate the efficacy of its regimen at RD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I : Rate of dose limiting toxicity
Phase II: Response rate
Key secondary outcomes Toxicity
Time to treatment failure
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 5-FU
Level 0 : 400mg/m2 bolus
Level 1,2: 500mg/m2 bolus
Level 3,4: 600mg/m2 bolus
l-Leucovorin
Level 0 : 200mg/m2/120min
Level 1-4: 250mg/m2/120min
Paclitaxel
Level 0,1: 60mg/m2/60min
Level 2,3: 80mg/m2/60min
Level 4 : 100mg/m2/60min

Administer three drugs on day1,8,15.
Repeat every 4 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) Histologically confirmed gastric adenocarcinoma
2) Age between 20 and 75 years
3) ECOG performance status (PS) of 0 to 2
4) Measurable disease by Response Evaluation Criteria in Solid Tumors Group (RECIST)
5) A life expectancy of at least 8 weeks
6) No prior chemotherapy or radiation therapy for gastric cancer, except follows;
1. Only oral fluoropyrimidine drug
2. Within 1 regimen
3. Administered for less than 1 year
4. Finished more than 6 months before
7) No prior chemotherapy or radiation therapy for other than gastric cancer
8) Adequate organ function
1. WBC>=3,000/mm3,<=12,000/mm3
2. platelets>=100,000/mm3
3. GOT, GPT<=100 U/L
4. T-Bil<=2.0 mg/dL
5. Cr<=1.5 mg/dL
6. CRP<=10mg/dL
9) No blood transfusion in last 2 weeks
10) Written informed consent
Key exclusion criteria 1) Diabetes with regular use of insulin or under poor control
2) Active ischemic heart disease
3) Severe arrhythmia
4) Symptomatic brain metastasis
5) Alcohol allergy
6) HBs antigen positive or HCV antibody positive
7) Massive abdominal effusion
8) Massive pleural effusin
9) Severe diarrhea
10) History of other active malignancy
11) Pregnancy, the desire to preserve fecundity, or lactating woman
12) Severe mental disorder
13) Need of IVH or enteral nutrition
14) Inadequate physical condition, as diagnosed by primary physician
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Matsubara
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Matsubara
Organization National Cancer Center Hospital
Division name Gastrointestinal Oncology Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045, Japan
TEL
Homepage URL
Email jmatsuba@kuhp.kyoto-u.ac.jp

Sponsor
Institute National Cancer Center Hospital,
Gastrointestinal Oncology Division
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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 国立がん研究センター中央病院、高知医療センター、神奈川県立がんセンター、三菱京都病院

Other administrative information
Date of disclosure of the study information
2006 Year 10 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
2006 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2010 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 10 Month 13 Day
Last modified on
2011 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000606

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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