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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000001685 |
Receipt No. | R000002014 |
Scientific Title | Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805) |
Date of disclosure of the study information | 2009/02/04 |
Last modified on | 2014/04/30 |
Basic information | ||
Public title | Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805) | |
Acronym | Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805) | |
Scientific Title | Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805) | |
Scientific Title:Acronym | Randomized phase II study of gemcitabine and S-1 combination therapy versus S-1 in advanced biliary tract cancer. (JCOG 0805) | |
Region |
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Condition | ||
Condition | biliary tract neoplasm | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to evaluate safety and efficacy of a gemicitabin plus S-1and S-1 alone as a first-line treatment for advanced biliary tract cancer patients. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | overall survival (1-year survival) |
Key secondary outcomes | progression-free survival, response rate, adverse events, severe adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
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: Patients receive gemcitabine(1,000 mg/m2, day1,8) plus S-1(60-100 mg/day, day1-14) every 3 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. | |
Interventions/Control_2 | B: Patients receive S-1 alone (80-120 mg/day, day1-28 every 6 weeks). It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity. | |
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) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer
2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Without CNS metastasis 5) Without moderate or more ascites/pleural effusion 6) No previous therapy against biliary tract cancer 7) No previous chemotherapy or radiotherapy against any other malignancies 8) ECOG PS of 0 or 1 9) Sufficient oral intake 10) Aged 20 to 79 years old 11) Adequate organ functions 12) Written informed consent |
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Key exclusion criteria | 1) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 3) Psychosis 4) Patients requiring systemic steroids medication 5) Interstitial pneumonia or fibroid lung 6) Watery diarrhea 7) Active bacterial or fungous infection 8) Severe complication 9) Patients requiring the administration of flucytosine, phenytoin or warfarin potassium 10) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Cancer Center Hospital | ||||||
Division name | Hepatobiliary and Pancreatic 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 | JCOG0805 Coordinating Office | ||||||
Division name | Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital | ||||||
Zip code | |||||||
Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan | ||||||
TEL | 03-3542-2511 | ||||||
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 | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 札幌厚生病院(北海道)
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) 国立がんセンター中央病院(東京都) 杏林大学医学部(東京都) 癌研究会有明病院(東京都) 神奈川県立がんセンター(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) 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) 大阪府立病院機構大阪府立成人病センター(大阪府) 国立病院機構大阪医療センター(大阪府) 国立病院機構四国がんセンター(愛媛県) 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) |
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/23763511 |
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 | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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=R000002014 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |