UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038585
Receipt number R000043970
Scientific Title A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma
Date of disclosure of the study information 2019/11/14
Last modified on 2019/11/14 18:45:06

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Basic information

Public title

A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Acronym

A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Scientific Title

A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Scientific Title:Acronym

A phase II clinical trial of neoadjuvant gemcitabine and S-1 with concurrent hypofractionated radiotherapy in patients with resectable and borderline resectable pancreatic ductal adenocarcinoma

Region

Japan


Condition

Condition

resectable and borderline resectable (BR-PV) pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of short-term neoadjuvant chemoradiation therapy for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Histological curative resection (R0 ratio)

Key secondary outcomes

Pathological responce rate, Incident of adverse event, Overall survival, Relapse free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

To investigate the frequency of histological curative resection following chemoradiation using gemcitabine(1000mg/m2) and S1(60mg/m2) combined with hypofactionated radiotherapy(30Gy/10fr) during two weeks for resectable and borderline resectable (BR-PV) pancreatic ductal adenocarcinoma

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

86 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with radiologically defined patentially resectable or borderline resectable (BR-PV) pancreatic ductal adenocarcinoma
2) Patients who have not undergone radiotherapy to the abdomen
3) Patients who have not undergone chemotherapy within 6 months
4) Patients with Performance status of 0/1
5) Patients with sustained organ function
6) Patients who received informed consent

Key exclusion criteria

1) Patients with pulmonary fibrosis or interstitial pneumonia
2) Patients with other active cancers
3) Patients who can not take medicine orally
4) Patients with severe allergies
5) Patients with watery diarrhea
6) Patients with severe co-morbid disease
7) Patients seems inadequate for this study by investigator(s)

Target sample size

54


Research contact person

Name of lead principal investigator

1st name Yasuyuki
Middle name
Last name Suzuki

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Gastroenterological Surgery

Zip code

761-0793

Address

1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL

087-898-5111

Email

szk@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name Hironobu
Middle name
Last name Suto

Organization

Faculty of Medicine, Kagawa University

Division name

Department of Gastroenterological Surgery

Zip code

761-0793

Address

1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

TEL

087-898-5111

Homepage URL


Email

hsuto@med.kagawa-u.ac.jp


Sponsor or person

Institute

Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University

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

Faculty of Medicine, Kagawa University

Address

1750-1, Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan

Tel

087-898-5111

Email

chosa@med.kagawa-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

香川大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 14 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

2019 Year 11 Month 14 Day

Date of IRB

2019 Year 11 Month 14 Day

Anticipated trial start date

2019 Year 11 Month 14 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2025 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 14 Day

Last modified on

2019 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name