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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name