UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001685 |
|---|---|
| Receipt number | 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 12:01:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Japan |
Condition
Condition
biliary tract neoplasm
Classification by specialty
| Hepato-biliary-pancreatic medicine |
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
| Medicine |
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
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
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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Okusaka |
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
| 1st name | |
| Middle name | |
| Last name | Chigusa Morizane |
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 or person
Institute
Japan Clinical Oncology Group(JCOG)
Institute
Department
Personal name
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
| 2009 | Year | 02 | Month | 04 | Day |
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
| 2008 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 04 | Day |
Last modified on
| 2014 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002014
