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
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
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)
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
