UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022936
Receipt No. 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 2016/06/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Keisuke Miwa
Organization Kurume University Hospital
Division name Multidisciplinary Treatment Cancer Center
Zip code
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
Middle name
Last name Keisuke Miwa
Organization Kurume University Hospital
Division name Multidisciplinary Treatment Cancer Center
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka, Japan
TEL 0942-35-3311
Homepage URL
Email miwa_keisuke@kurume-u.ac.jp

Sponsor
Institute Kurume University Hospital
Multidisciplinary Treatment Cancer Center
Institute
Department

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
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 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
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
2016 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 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
2016 Year 06 Month 29 Day
Last modified on
2016 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.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


Contact us.