UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013803
Receipt number R000016114
Scientific Title A phase II clinical trial of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer (HIMAT1326)
Date of disclosure of the study information 2014/04/24
Last modified on 2018/10/24 17:14:41

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Basic information

Public title

A phase II clinical trial of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer (HIMAT1326)

Acronym

Carbon-ion radiotherapy with S-1 chemotherapy for locally advanced pancreatic cancer (HIMAT1326)

Scientific Title

A phase II clinical trial of carbon-ion radiotherapy and concurrent S-1 chemotherapy for locally advanced pancreatic cancer (HIMAT1326)

Scientific Title:Acronym

Carbon-ion radiotherapy with S-1 chemotherapy for locally advanced pancreatic cancer (HIMAT1326)

Region

Japan


Condition

Condition

locally advanced pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of carbon-ion radiotherapy with S-1 chemotherapy for locally advanced pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

two year survival rate

Key secondary outcomes

local control rate, progression free survival, complication rate


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 Other

Interventions/Control_1

Carbon-ion radiotherapy
Chemotherapy (S-1)

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Pathologically diagnosed pancreatic invasive ductal carcinoma
2) No distant metastasis
3) T4 (UICC)
4) No evidence of gastro-duodenal ulcer
5) Age between 20 and 80 years old
6) PS 0-2
7) No past history of treatment for pancreatic cancer
8) Sufficient major organ function
9) Informed consent by patient

Key exclusion criteria

1) Invasion to mucosal membrane of stomach or intestine
2) Ascites on CT scan
3) Metallic stent at the bile duct
4) Use of flu cytosine, phenytoin, or warfarin potassium
5) Uncontrolled severe infection
6) Uncontrolled severe complication
7) Active double cancers
8) Past history of irradiation to the target region
9) Other medical or psychological unsuitable reasons

Target sample size

45


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiyuki Shioyama

Organization

SAGA HIMAT Foundation

Division name

Ion Beam Therapy Center

Zip code


Address

3049, Harakoga-machi, Tosu, Saga, 841-0077

TEL

0942-81-1897

Email

shioyama-yoshiyuki@saga-himat.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kotaro Terashima

Organization

SAGA HIMAT Foundation

Division name

Ion Beam Therapy Center

Zip code


Address

3049, Harakoga-machi, Tosu, Saga, 841-0077

TEL

0942-81-1897

Homepage URL


Email

terashima-kotaro@saga-himat.jp


Sponsor or person

Institute

Ion Beam Therapy Center

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


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 04 Month 24 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

2014 Year 03 Month 19 Day

Date of IRB


Anticipated trial start date

2014 Year 04 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 24 Day

Last modified on

2018 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016114


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name