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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000138
Receipt No. R000000205
Scientific Title Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)
Date of disclosure of the study information 2005/09/08
Last modified on 2015/10/22

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Basic information
Public title Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)
Acronym Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)
Scientific Title Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)
Scientific Title:Acronym Randomized phase II study of best available 5-FU versus low-dose Paclitaxiel in gastric cancer with peritoneal metastasis refractory to 5-FU containing regimen(JCOG0407)
Region
Japan

Condition
Condition gastric neoplasm
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate safety and efficacy of low-dose paclitaxel as a second-line treatment for recurrence or unresectable gastric cancer patients with peritoneal metastasis who is refractory to fluoropyrimidine analogs containing regimen in comparison with best available 5-FU.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Best available 5-FU
In the best available 5-FU arm, 5-FU continuous infusion (5-FUci) regimen or sequential methotrexate (MTX) and 5-fluorouracil (MTX/5-FU) regimen is selected according to patients' prior chemotherapy: If the prior chemotherapy included 5-FU bolus infusion or MTX, 5-FUci regimen will be selected. The other cases select MTX/5-FU regimen.
The 5-FUci regimen consists of 5-FUci (800 mg/m2/day, days 1 through 5), every 4 weeks. The MTX/5-FU regimen consists of MTX bolus infusion (100 mg/m2/day, day 1), 5-FU bolus infusion (600 mg/m2/day, day 1) after MTX, and l-leucovorin administration by oral or infusion (10 mg/m2/6 hour, days 2 through 3), which are repeated weekly.
Interventions/Control_2 B: Low dose paclitaxel
The low-dose paclitaxel regimen consists of 1-hour paclitaxel infusion (80 mg/m2/day, days 1, 8, and 15) every 4 weeks.
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) they have histologically proven recurrence or unresectable gastric adenocarcionoma
(2) they have peritoneal metastasis
(3) they have no symptomatic central nerve system metastasis
(4) they are aged 20-75 years
(5) they have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2
(6) In recurred cases, they had received fluoropirimidine analogs containing regimen as adjuvant chemotherapy. The period from last administration of adjuvant chemotherapy should be within 24 days. In unresectable cases, they had received fluoropirimidine analogs containing regimen as 1st line chemotherapy. The period from last administration of 1st line chemotherapy should be within 6 weeks. The fluoropirimidine analogs containing regimen is as follows: fluorouracil (5-FU), uracil and tegafur (UFT), tegafur, gimeracil, oteracil potassium (TS-1), 1-hexylcarbamoyl-5-fluorouracil (HCFJ), tegafur, 5'-DFUR;doxifluridine (FT)
(7) their prior chemotherapy did not include taxanes nor bolus infusion and continuous infusion of 5-FU (i.e., FOLFOX, FOLFILI, FAMTX, or ECF)
(8) they have sufficient organ function
(9) they have no history of gastrointestinal surgery
(10) they have no history of chemotherapy except for gastric cancer
(11) they have no history of radiotherapy for any malignancy
(12) they provided written informed consent
Key exclusion criteria (1) diabetes mellitus, uncontrolled or controlled with insulin
(2) unstable angina, or myocardial infarction within 6 months prior to the study
(3) arrhythmia, needing medical intervention
(4) hypersensitivity to alcohol
(5) HBs antigen or their HCV antibody are positive
(6) massive pleural effusion
(7) Grade 3-4 diarrhea (CTCAE ver3.0)
(8) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
(9) pregnant or lactating women
(10) severe mental disease
(11) not appropriate for the trial at the physician's assessment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Takiuchi, MD, PhD
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 daigakumachi, takatuki-shi, Osaka, 569-8686, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroya Takiuchi, MD, PhD
Organization JCOG0407 coordinating Office
Division name Second Department of Internal Medicine,Osaka Medical College
Zip code
Address 2-7 daigakumachi, takatuki-shi, Osaka, 569-8686, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour 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 北海道大学病院(北海道)
斗南病院(北海道)
岩手県立中央病院(岩手県)
東北大学病院(宮城県)
山形県立中央病院(山形県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
自治医科大学(栃木県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
千葉県がんセンター(千葉県)
総合病院国保旭中央病院(千葉県)
国立がんセンター中央病院(東京都)
昭和大学病院(東京都)
癌研究会有明病院(東京都)
北里大学東病院(神奈川県)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
佐久総合病院(長野県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
京都大学医学部附属病院(京都府)
大阪市立総合医療センター(大阪府)
大阪医科大学(大阪府)
神戸大学医学部(兵庫県)
兵庫県立がんセンター(兵庫県)
国立病院機構四国がんセンター(愛媛県)
高知医療センター(高知県)

Other administrative information
Date of disclosure of the study information
2005 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26386560
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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
2005 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2005 Year 09 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2010 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 08 Day
Last modified on
2015 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000205

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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