UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022936
Receipt number R000026435
Scientific Title Phase II trial of an alternating regimen consisting of first-line modified FOLFIRINOX and Gemcitabine plus nab-Paclitaxel for patients with metastatic pancreatic cancer
Date of disclosure of the study information 2016/07/01
Last modified on 2020/01/01 10:56:52

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Basic information

Public title

Phase II trial of an alternating regimen consisting of first-line modified FOLFIRINOX and Gemcitabine plus nab-Paclitaxel for patients with metastatic pancreatic cancer

Acronym

KSCOT-01

Scientific Title

Phase II trial of an alternating regimen consisting of first-line modified FOLFIRINOX and Gemcitabine plus nab-Paclitaxel for patients with metastatic pancreatic cancer

Scientific Title:Acronym

KSCOT-01

Region

Japan


Condition

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety from clinical outcome in patients with metastatic pancreatic cancer who received alternating chemotherapy of first-line modified FOLFIRINOX and gemcitabine plus nab-paclitaxel

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Overall survival
Objective response rate
Safety


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

Interventions/Control_1

Alternating chemotherapy of modified FOLFIRINOX and gemcitabine plus nab-paclitaxel
< modified FOLFIRINOX regimen >
Fluorouracil:2400mg/m2 day 1, 15, q4weeks
Leucovorin:200mg/m2 day 1, 15, q4weeks
Irinotecan:150mg/m2 day 1, 15, q4weeks
Oxaliplatin:85mg/m2day 1, 15, q4weeks
< Gemcitabine plus nab-Paclitaxel regimen >
Gemcitabine:1000mg/m2 day 1, 8, 15, q4weeks
nab-Paclitaxel:125mg/m2 day 1, 8, 15, q4weeks
Alternating chemotherapy every four weeks until progression disease

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed adenocarcinoma or adenosquamouscarcinoma.
2) Patients with unresectable recurrence or metastatic pancreatic cancer
3) Patients without any previous treatment (radiotherapy, chemotherapy).
4) Age between 20 and 70 years.
5) ECOG performance status 0 or 1.
6) Patients with measurable lesion.
7) Sufficient functions of important organs
WBC<=12,000/mm3
Neurtophils>=1,500/mm3
Platelets>=100,000/mm3
Hemoglobin>=9.0g/dL
AST<=2.5 X ULN
ALT<=2.5 X ULN
Total bilirubin<=1.25 X ULN
Creatinine<=1.5mg/dl
8) Patients without clinical abnormality in urinalysis.
9) Patients without active hepatitis B.
10) Expected survival longer than 3 months.
11) Written informed consent to participate.

Key exclusion criteria

1) History of hypersensitivity reaction
2) Homozygote of UGT1A1*6 or UGT1A1*28, heterozygote of UGT1A1*6 and UGT1A1*28
3) Brain metastasis
4) Pulmonary fibrosis or interstitial pneumonia
5) Active infection
6) Other severe complications, such as heart failure, renal failure, hepatic failure, active ulcer, bowel obstruction and diabetes with clinically problem
7) Active another cancer
8) Required treatment with steroid
9) History of the peripheral arterial disease (Buerger disease, episodes of claudication)
10) History of collagenosis (SLE, systemic scleroderma, polyarteritis nodosa)
11) Pregnant or possibility pregnancy or nursing women
12) Men with hope of the pregnancy of the partner
13) Mental disorder which become problem on clinical practice
14) Physician judged improper to entry this trial

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Keisuke
Middle name
Last name Miwa

Organization

Kurume University Hospital

Division name

Multidisciplinary Treatment Cancer Center

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

TEL

0942-35-3311

Email

miwa_keisuke@kurume-u.ac.jp


Public contact

Name of contact person

1st name Keisuke
Middle name
Last name Miwa

Organization

Kurume University Hospital

Division name

Multidisciplinary Treatment Cancer Center

Zip code

830-0011

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

TEL

0942-35-3311

Homepage URL


Email

miwa_keisuke@kurume-u.ac.jp


Sponsor or person

Institute

Kurume University Hospital
Multidisciplinary Treatment Cancer Center

Institute

Department

Personal name



Funding Source

Organization

None

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 Ethical Committee of Kurume University

Address

67 Asahi-machi, Kurume, Fukuoka, Japan

Tel

0942-35-3311 (5507)

Email

i_rinri@kurume-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

久留米大学病院


Other administrative information

Date of disclosure of the study information

2016 Year 07 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

10

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

Terminated

Date of protocol fixation

2016 Year 05 Month 20 Day

Date of IRB

2016 Year 06 Month 08 Day

Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date

2019 Year 12 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

2016 Year 06 Month 29 Day

Last modified on

2020 Year 01 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026435


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name