UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015330 |
|---|---|
| Receipt number | R000017827 |
| Scientific Title | A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer. |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2014/10/02 22:48:53 |
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Basic information
Public title
A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.
Acronym
A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.
Scientific Title
A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.
Scientific Title:Acronym
A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.
Region
| Japan |
Condition
Condition
Biliary tract cancer
(Intrahepatic cholangiocarcinoma, Extrahepatic cholangiocarcinoma, Gallbladder carcinoma)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Resection rate
Key secondary outcomes
1. Overall survival
2. Disease free survival
3. Progression free survival
4. Tumor response rate
5. Adverse events
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
Neoadjuvant chemotherapy: 3 course of gemcitabine and cisplatin combination therapy (21days for one course: day 1 and 8 gemcitabine 1000mg/m2, cisplatin 25mg/m2)
Adjuvant chemotherapy: 6 course of gemcitabine therapy (28days for one course: day 1, 8, and 15 gemcitabine 1000mg/m2)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Initially unresectable locally advanced biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma) proved by histological or cytological or graphical examination.
2. No distant metastasis.
3. Local invasion of the hepatic artery to be unable to reconstruct.
Local invasion of the portal vein to be unable to reconstruct.
Local invasion of the hepatic vein to be unable to reconstruct.
Extensive infiltration of the bile duct to be unable to achieved a curative resection.
Extensive hepatic invasion to be unable to excise due to insufficient remnant liver volume even after portal vein embolization
4. Age 20 or more
5. No history of primary chemotherapy and/or radiation therapy.
6. EOCG performance status 0-1
7. Sufficient organ function defined as:
WBC > 3,000/mm3
ANC > 1,500/mm3
Hb > 9.0g/dl
PLT > 100,000/mm3
T-Bil < upper limit X 5
AST/ALT < upper limit X 5
Creatinine < upper limit X 1.5
8. Written informed consent
Key exclusion criteria
1. Pulmonary fibrosis or interstitial pneumonia
2. Severe myelosuppression
3. Pregnant female, possibly pregnant females, females wishing to become pregnant, and females feeding babies.
4. Serious renal dysfunction
5. Serious liver dysfunction
6. Patients with severe allergy
7. History of breast or lung radiation
8. Active infection
9. Patient with uncontrollable pleural effusion and/or severe edema
10. Active double cancer
11. Severe complications including uncontrollable diabetes mellitus.
12. Severe mental disorder
13. Inadequate physical condition, as diagnosed by primary physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Miyazaki |
Organization
Chiba University Graduate School of Medicine
Division name
Depertment of General Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2103
masaru@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Kato |
Organization
Chiba University Graduate School of Medicine
Division name
Depertment of General Surgery
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2103
Homepage URL
akato@faculty.chiba-u.jp
Sponsor or person
Institute
Adjuvant therapy for BTC Research Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2014 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017827
