UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042932
Receipt number R000046908
Scientific Title A phase I/II study of neoadjuvant chemoradiotherapy for pancreatic cancer.
Date of disclosure of the study information 2021/01/31
Last modified on 2021/08/01 16:43:51

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Basic information

Public title

A phase I/II study of neoadjuvant chemoradiotherapy for pancreatic cancer.

Acronym

J-PACS 05

Scientific Title

A phase I/II study of neoadjuvant chemoradiotherapy for pancreatic cancer.

Scientific Title:Acronym

J-PACS 05

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the safety and efficacy of GnP therapy combined with IMRT for locally advanced pancreatic cancer including BR pancreatic cancer and UR-LA pancreatic cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Phase I; Setting the optimal radiation dose
Phase II; Conversion ratio

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Gemcitabine + NabPTx: Gemcitabine 1000mg / m2 and NabPTx 125mg / m2 are intravenously infused on the same day, and the treatment is given once a week for 3 consecutive weeks, and the drug is withdrawn in the 4th week.

Intensity-modulated radiotherapy (IMRT): Start after the end of 2nd GnP administration and before the end of 1 course (Day 28). The irradiation dose is 1.8 Gy at a time, and it is administered 23 to 30 times.

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) Patients with pancreatic cancer confirmed by histology or cytology
2) Patients with locally advanced pancreatic cancer without distant metastases and considered difficult to resect curatively.
3) No prior treatment history (surgical excision, chemotherapy, radiation, etc.)
4) Age at registration is 20 years old or older and under 80 years old
5) Performance status (ECOG) is 0, 1
6) Expected to survive for 3 months or more from the start of treatment
7) The functions of major organs (bone marrow, liver, kidney, lung, etc.) are maintained.
8) Sufficient urine volume is secured (approximate: 1200 ml / day or more)
9) Cases that can be taken orally
10) Written consent of the person has been obtained

Key exclusion criteria

1) Exclude non-curative factors found during radical resection
2) Have overt pulmonary fibrosis or interstitial pneumonia
3) Concomitant with active infectious diseases (HB, HCV, HIV infection, etc.)
4) Have uncontrollable diabetes, heart failure, angina, arrhythmia and myocardial infarction within 6 months of onset
5) Have watery diarrhea
6) Cases using flucytosine and phenytoin
7) Pregnant, lactating and likely or willing to become pregnant
8) Have a serious drug allergy
9) Have active double cancer (not applicable to cases 5 years after complete cure)
10) Have other serious complications
11) Have severe neuropsychiatric symptoms, renal impairment, hearing impairment
12) Chickenpox patients
13) Previous treatment history (surgical excision, chemotherapy, radiation, etc.) for this disease
14) In addition, the doctor in charge judged that it was inappropriate to carry out this study safely.

Target sample size

58


Research contact person

Name of lead principal investigator

1st name Tadashi
Middle name
Last name Uwagawa

Organization

The Jikei University school of medicine

Division name

Department of Surgery

Zip code

105-8461

Address

3-25-8, Nishi-shinbashi, Minatoku, Tokyo

TEL

0334331111

Email

uwatadashi@msn.com


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name Uwagawa

Organization

The Jikei University school of medicine

Division name

Department of Surgery

Zip code

105-8461

Address

3-25-8, Nishi-shinbashi, Minatoku, Tokyo

TEL

0334331111

Homepage URL


Email

uwatadashi@msn.com


Sponsor or person

Institute

The Jikei University school of medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University school of medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Jikei University Certified Review Board

Address

3-25-8, Nishi-shinbashi, Minatoku, Tokyo

Tel

0334331111

Email

crb@jikei.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

2021 Year 01 Month 31 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

2020 Year 10 Month 06 Day

Date of IRB

2020 Year 10 Month 15 Day

Anticipated trial start date

2020 Year 10 Month 06 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

2021 Year 01 Month 06 Day

Last modified on

2021 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name