UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010922
Receipt number R000012780
Scientific Title Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer
Date of disclosure of the study information 2013/06/11
Last modified on 2019/06/16 08:53:23

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Basic information

Public title

Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer

Acronym

HORE PC01

Scientific Title

Randomized phase II study with S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for patients with pancreatic cancer

Scientific Title:Acronym

HORE PC01

Region

Japan


Condition

Condition

Resected pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the clinical effectiveness of the S-1 (4week treatment and 2week rest) or S-1 (Alternate day administration) adjuvant chemotherapy for the patients with pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

treatment complete rate

Key secondary outcomes

Relapse free survival, overall survival, Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

S-1by Alternate day administration for 180days (6months) (1 course=6weeks, 42days).

Interventions/Control_2

S-1 for 28 days with 14 days rest for 180days (6months) (1 course=6weeks, 42days).

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) Resected cases with histologically proven invasive ductal carcinoma of the pancreas
2) According to the UICC classification,
a) Stage I or II, or III in whom celiac artery resection was performed
b) R0 or R1
c) Cancer negative for washing cytology of the abdominal cavity
3) No distant metastasis nor malignant ascites
4) Adequate oral intakes
5) Aged 20 years or older
6) An Eastern Cooperative Oncology Group performance status of 0 or 1
7) No prior history of chemotherapy nor radiation therapy within three years
8) Within 10 weeks after operation
9) Sufficient organ function
10) Written informed consent

Key exclusion criteria

1) Prior history of S-1 therapy
2) Recurrent disease on enrollment
3) Massive ascites or pleural effusion
4) Plumonary fibrosis or interstitial pneumonia
5) Severe diarrhea
6) Severe infection
7) Blood transfusion within two weeks
8) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc
9) Severe mental disorder
10) Severe drug allergy
11) Other active malignancy
12) Pregnancy, breast feeding, or women who desire to preserve fecundity or Men who desire to have children
13) Regular use of frucitocin, fenitoin or warfarin
14) Inadequate physical condition, as diagnosed by primary physician

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Konno

Organization

Hamamatsu University School of Medicine

Division name

Second Department of Surgery

Zip code

431-3192

Address

1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan

TEL

053-435-2279

Email

kon_6416@hama-med.ac.jp


Public contact

Name of contact person

1st name Takanori
Middle name
Last name Sakaguchi

Organization

Hamamatsu University School of Medicine

Division name

Second Department of Surgery

Zip code

431-3192

Address

1-20-1, Handayama Hamamatsu Shizuoka 431-3192, Japan

TEL

053-435-2279

Homepage URL


Email

saka1119@hama-med.ac.jp


Sponsor or person

Institute

HORE

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

iwata city hospital
Hamamatsu medical center
shizuoka city shimizu hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hamamatsu University School of Medicine

Address

1-20-1, Handayama Hamamatsu Shizuoka 431-3192

Tel

053-435-2111

Email

rinri@hama-med.ac.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

静岡


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 11 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

Open public recruiting

Date of protocol fixation

2013 Year 05 Month 31 Day

Date of IRB

2013 Year 04 Month 01 Day

Anticipated trial start date

2013 Year 06 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2018 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 06 Month 10 Day

Last modified on

2019 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012780


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name