UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000502 |
|---|---|
| Receipt number | 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 09:22:53 |
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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
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
jmatsuba@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
National Cancer Center Hospital,
Gastrointestinal Oncology Division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000606
