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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004494
Receipt No. R000005371
Scientific Title Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers
Date of disclosure of the study information 2010/11/03
Last modified on 2011/12/08

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Basic information
Public title Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers
Acronym Clinical trila by chemotherapy-combined peptide vaccination for metastatic biliary tract cancers
Scientific Title Phase I/II clinical trila by gemcitabine+CDDP- or S-1- combined peptide vaccination for metastatic biliary tract cancers
Scientific Title:Acronym Clinical trila by chemotherapy-combined peptide vaccination for metastatic biliary tract cancers
Region
Japan

Condition
Condition metastatic biliary tract cancers
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Two-step phase I/II clinical trial: recommended doses will be determined by phase I, and over-all survival, DCR, RR, PFS, and AE will be examined by phase II. Primary endpoint is OS, compared with the result obtained by ABC-02 trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes DCR, RR, PFS, AE, immunological reactions (CTL, CD8, regT)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine Gene
Interventions/Control_1 emcitabine+CDDP/vaccination (first line), S-1/vaccination (second line).
genetic type of HLA-A is blinded and will be key-open at the end of trial.
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. Pathologically diagnosed biliary tract cancers -bile duct cancer, gall bladder cancer or ampulla cancer of duodenum.

2. Primary tumor is not curatively resectable or metastatic lesion is not curatively resectable.

3. Patient, obtains measurable lesions.

4. Patient, has no previous treatments other than surgery. Previous treatments include artery-infusional chemotherapy and postoperative adjuvant chemotherapy.

5. older than 19 years.

6. PS=0, 1 or 2 (ECOG).

7. Oral intake is possible.

8. Major organ functions, such as bone marrow, heart, liver, kidney, are obtained, as follows (data within 14 days before trial registration)
WBC>=3500/microL and <=10000/microL
platelets>=100000/microL
lymphocytes>=1000/microL
GOT(AST)<=100IU/L
GPT(ALT)<=100IU/L
T-Bilirubin<=2.0mg/dL (<=3.0mg/dL cases with biliary drainage)
creatinine<=1.2mg/dL
CCR>=50mi/min (Cockcroft-Gault)

9. Patients expected to live more than three months

10. Documented informed consent
Key exclusion criteria Patients
-obtains previous radiation therapy for biliary tract cancers.
-obtains brain metastasis not manipulated.
-obtains active duplicated neoplastic diseases.
-obtains co-morbidity as follows; intestinal paralysis, intestinal obstruction, diabetes mellitus, hypertension, angina pectoris, livet cirrhosis, pneumonitis, emphysema.
-is HIV-positiveness
-has past history of severe allergic reaction for gemcitabine, cisplatin, or TS-1.
-obtains ascites or pleural effusion that needs treatment.
-has severe diarrhea or GI bleeding.
-has treatment by frucitosine
-is pregnat or can be pregnant.
-desires partners pregnancy.
-has HLA-A genotype opened.
Target sample size 22

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takahiro Mori, MD PhD
Organization Tohoku University Graduate School of Medicine
Division name Tohoku University Cancer Center
Zip code
Address 1-1 Seiryo-cho, Aobaku, Sendai
TEL 022-717-7087
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Takahiro Mori, MD PhD
Organization Tohoku University Graduate School of Medicine
Division name Tohoku University Cancer Center
Zip code
Address
TEL
Homepage URL
Email tamori@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2010 Year 11 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 Terminated
Date of protocol fixation
2010 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 12 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
2010 Year 11 Month 01 Day
Last modified on
2011 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005371

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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