UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036449
Receipt number R000041509
Scientific Title Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy
Date of disclosure of the study information 2019/04/17
Last modified on 2023/06/05 14:21:32

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Basic information

Public title

Randomized Phase II study of adjuvant chemotherapy with gemcitabine plus cisplatin versus gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy(KHBO1901)

Acronym

Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy

Scientific Title

Randomized Phase II study of adjuvant chemotherapy with GC versus GS in patients with BTC undergoing curative resection without major hepatectomy

Scientific Title:Acronym

KHBO1901

Region

Japan


Condition

Condition

biliary tract cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparison of the efficacy for GC and GS as adjuvant chemotherapy in patients with BTC undergoing curative resection without major hepatectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Recurrence-free survival (2-year recurrence-free survival rate)

Key secondary outcomes

1)Overall survival
2)Proportion of treatment completion
3)Relative dose intensity
4)Proportion of adverse events
5)Relapse-free survival rate and overall survival of lymph node positive/lymph node negative case
6)Relapse-free survival rate and overall survival of R0/R1 case
7)Relapse-free survival rate and overall survival of each primary site


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Adjuvant GC chemotherapy consisted of
intravenous GEM(1000mg/mm2) and CDDP (25mg/m2) on days 1 and 8, with 1 week rest.

Interventions/Control_2

Adjuvant GS chemotherapy consisted of
intravenous GEM(800mg/mm2) on days 1 and 8, and oral S-1(50mg/mm2/day) administered
twice daily on days 1-14, with a 1 week rest.

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) Diagnosed as having biliary tract adenocarcinoma or adenosquamous carcinoma(IHBD, EHBD, GB or AV cancer) in resected specimen.
2) R0 or R1 residual disease.
3) Pathological disease stage according to the UICC classification, seventh Edition: T2-4, N0, M0 or T1-4, N1, M0 (for patients with EHBD, GB or AV cancer), or T1-4, N0-1, M0 (for patients with IHBD cancer).
4) Age over 20 years
5) ECOG performance status 0 or 1
6)No treatment other than surgery except of drainage
7) No distant metastasis according to the radiological findings after operation.
8) Adequate organ functions
a) Neutrophil count >=1,500/mm3
b) Platelet count >= 100,000/mm3
c) Serum aspartate transaminase <=150U/l
d) Serum alanine transaminase <=150U/l
e) Serum total bilirubin <=1.5 mg/dl
f) Serum creatinine <=1.2 mg/dl
g) Creatinine clearance >=60 ml/min
9) Adequate oral intake.
10) Between 3 and 12 weeks after resection.
11) Written informed consent.

Key exclusion criteria

1)Distant metastasis except of positive CY
2) Not performed lobectomy
3) Other concurrent active cancer (synchronous double cancer or heterochronous double cancer with a disease-free interval of 3 years or shorter, excluding lesions consistent with intraepithelial cancer, i.e., intramucosal cancer that are assessed as cured by endoscopical treatment.)
4) Patients with a history of severe drug hypersensitivity or drug allergy.
5) Serious complicating disorders (Interstitial pneumonia, pulmonary fibrosis or severe emphysema, hepatic cirrhosis, uncontrollable-diabetes, cardiac disease, renal failure, liver failure, hemorrhagic peptic ulcer etc).
6) Active infection requiring systemic therapy
7) Pregnant or lactating women, women with childbearing potential, males males who wish a pregnancy of his partner.
8) Severe psychiatric disease.
9) Inappropriate for this study judged by the attending physician

Target sample size

106


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Yanagimoto

Organization

Kobe University Graduate School of Medicine

Division name

Division of Hepato-biliary-pancreatic surgery, Department of Surgery

Zip code

650-0017

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan

TEL

078-382-6302

Email

yanagimh@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Ioka

Organization

Kansai Hepato-Biliary Oncology Group (KHBO)

Division name

Department of Cancer Survey and Gastrointestinal Oncology,Osaka International Cancer Institute

Zip code

541-8567

Address

3-1-69 Otemae, Chuo-ku, Osaka-shi, Osaka , Japan

TEL

06-6945-1181(6383)

Homepage URL


Email

ioka-ta@umin.ac.jp


Sponsor or person

Institute

Kansai Hepatobiliary Oncology Group (KHBO)

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Osaka International Cancer Institute

Address

3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan.

Tel

06-6945-1181

Email

rinri01@opho.jp


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

2019 Year 04 Month 17 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

No longer recruiting

Date of protocol fixation

2019 Year 02 Month 24 Day

Date of IRB

2019 Year 05 Month 08 Day

Anticipated trial start date

2019 Year 08 Month 23 Day

Last follow-up date

2025 Year 05 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 09 Day

Last modified on

2023 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name