UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041309
Receipt number R000047172
Scientific Title A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/04 15:45:30

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Basic information

Public title

A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer

Acronym

A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer

Scientific Title

A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer

Scientific Title:Acronym

A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Radiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the pathogenesis of hypoxic regions of pancreatic cancer that are resistant to treatment, we used hypoxic PET and pathology findings, predicting the effects of chemoradiotherapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between hypoxic regions and 2-year overall survival

Key secondary outcomes



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

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Hypoxic PET

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

The pancreatic cancer patients who are going to receive chemoradiotherapy at Kyoto University Hospital

Key exclusion criteria

1) Patients in extremely poor general condition.
2) Patients who have a history of previous abdominal radiotherapy that overlaps with the irradiation field of the current pancreatic cancer.

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Mizowaki

Organization

Kyoto University Graduate School of Medicine

Division name

Radiation Oncology and Imaging Applications

Zip code

6068507

Address

54 Shougoin-kawaramachi sakyoku Kyoto city Kyoto prefecture Japan

TEL

075-751-3762

Email

mizo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Michio
Middle name
Last name Yoshimura

Organization

Kyoto University Graduate School of Medicine

Division name

Radiation Oncology and Imaging Applications

Zip code

6068507

Address

54 Shougoin-kawaramachi sakyoku Kyoto city Kyoto prefecture Japan

TEL

075-751-3762

Homepage URL


Email

myossy@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

54 Shougoin-kawaramachi sakyoku Kyoto city Kyoto prefecture Japan

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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



Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 01 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

Preinitiation

Date of protocol fixation

2020 Year 08 Month 04 Day

Date of IRB


Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 04 Day

Last modified on

2020 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047172


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name