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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000123 |
Receipt No. | R000000183 |
Scientific Title | Randomized phase III study of 5-FU continuous infusion (5FUci) versus MTX+5-FU sequential therapy (MF) in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU) |
Date of disclosure of the study information | 2005/09/07 |
Last modified on | 2014/02/21 |
Basic information | ||
Public title | Randomized phase III study of 5-FU continuous infusion (5FUci) versus MTX+5-FU sequential therapy (MF) in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU) | |
Acronym | Randomized phase III study of 5-FU versus MTX+5-FU in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU) | |
Scientific Title | Randomized phase III study of 5-FU continuous infusion (5FUci) versus MTX+5-FU sequential therapy (MF) in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU) | |
Scientific Title:Acronym | Randomized phase III study of 5-FU versus MTX+5-FU in gastric cancer with peritoneal metastasis (JCOG0106-MF, MF/5FU) | |
Region |
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Condition | ||
Condition | gastric cancer with peritoneal metastasis | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To develop effective chemotherapy regimen agasinst gastric cancer with peritoneal metastasis |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | overall survival |
Key secondary outcomes | oral intake, toxicity |
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 |
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Interventions/Control_1 | A: 5-FU continuous infusion | |
Interventions/Control_2 | B: MTX+5-FU sequential therapy | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | (1) histologic confirmation of gastric adenocarcinoma
(2) inoperable metastatic disease or recurrent metastatic disease after surgery (3) disease with peritoneal metastasis (4) 20 years or more but less than 75 years (5) performance status 2 or less on the Eastern Cooperative Oncology Group scale (6) no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy (7) no prior chemotherapy or radiotherapy for other disease except for gastric cancer (8) adequate bone marrow function, adequate liver function, and adequate renal function (9) no prior transfusion for anemia (10) provision of written informed consent |
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Key exclusion criteria | (1) Massive pleural effusion
(2) brain metastasis with symptoms (3) severe diarrhea (4) other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) (5) other active malignancies |
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Target sample size | 236 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital | ||||||
Division name | Gatrointestinal Oncology Division | ||||||
Zip code | |||||||
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN | ||||||
TEL | |||||||
Public contact | |||||||
Name of contact person |
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Organization | JCOG0106 coordinating Office | ||||||
Division name | Gatrointestinal Oncology Division, National Cancer Center Hospital | ||||||
Zip code | |||||||
Address | 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 JAPAN | ||||||
TEL | |||||||
Homepage URL | http://www.jcog.jp/ | ||||||
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 | |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | NCT00149201 |
Org. issuing International ID_1 | ClinicalTrials.gov by NLM |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北海道大学医学部(北海道)
斗南病院(北海道) 青森県立中央病院(青森県) 岩手県立中央病院(岩手県) 東北大学医学部(宮城県) 山形県立中央病院(山形県) 茨城県立中央病院・茨城県立地域がんセンター(茨城県) 栃木県立がんセンター(栃木県) 埼玉県立がんセンター(埼玉県) 埼玉医科大学病院(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) 横浜市立大学医学部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) 国立病院機構名古屋医療センター(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) 大阪医科大学(大阪府) 神戸大学医学部(兵庫県) 兵庫県立成人病センター(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) 国立病院機構九州がんセンター(福岡県) 九州大学病院(福岡県) 熊本地域医療センター(熊本県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | http://www.ncbi.nlm.nih.gov/pubmed/24014884 |
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 |
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Anticipated trial start date |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000183 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |