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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021526
Receipt No. R000024550
Scientific Title Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma
Date of disclosure of the study information 2016/03/18
Last modified on 2016/04/01

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Basic information
Public title Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma
Acronym Phase I study of third-line FOLFIRINOX for pancreatic adenocarcinoma
Scientific Title Phase I study of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) unresectable Gem/S-1 refractory pancreatic adenocarcinoma
Scientific Title:Acronym Phase I study of third-line FOLFIRINOX for pancreatic adenocarcinoma
Region
Japan

Condition
Condition unresectable Gem/S-1 refractory pancreatic adenocarcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the maximum tolerated dose (MTD) and to evaluate the safety of third-line FOLFIRINOX (oxaliplatin, irinotecan, 5-FU, and leucovorin) for unresectable Gem/S-1 refractory pancreatic adenocarcinoma patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes occurrence of side effect of preoperative gemcitabine based chemoradiation therapy
Key secondary outcomes Response Rate, Overall Survival (OS) , Progression free survival (PFS)

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 This dose-escalation study was conducted as a phase I trial with a 3+3 design to estimate MTD of third-line FOLFIRINOX.


Level1(L-OHP 55mg/m2, CPT-11 75mg/m2, 5FU 1200mg/m2 )
Level2(L-OHP 55mg/m2, CPT-11 75mg/m2, 5FU 1800mg/m2 )
Level3(L-OHP 55mg/m2, CPT-11 100mg/m2, 5FU 1800mg/m2 )
Level4(L-OHP 65mg/m2, CPT-11 100mg/m2, 5FU 1800mg/m2 )
Level5(L-OHP 65mg/m2, CPT-11 100mg/m2, 5FU 2400mg/m2 )
Level6(L-OHP 65mg/m2, CPT-11 120mg/m2, 5FU 2400mg/m2 )
Level7(L-OHP 85mg/m2, CPT-11 120mg/m2, 5FU 2400mg/m2 )
Level8(L-OHP 85mg/m2, CPT-11 150mg/m2, 5FU 2400mg/m2 )
Level9(L-OHP 85mg/m2, CPT-11 180mg/m2, 5FU 2400mg/m2 )
Level10(L-OHP 85mg/m2, CPT-11 180mg/m2, 5FU 2400mg/m2 )
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma
2. Performance Status 0-1 (ECOG)
3. WBC <=12,000/mm3
Neutrophils >=1,500/mm3
Platelets >=100,000/mm3
Hemoglobin >=9.0g/dL
GOT, GPT: less than 3-fold of the upper limit of normal range
Total bilirubin <3.0mg/dL
Albumin >=3.5g/dL
Creatinine clearance >=50ml/min
4. Life expectancy of at least 3 months
5. Written informed consent
Key exclusion criteria 1. Poorly controlled ascites
2. Patients homozygous for UGT1A1*6 or UGT1A1*28, or double heterozygotes (*6/*28)
3. Active infection
4. Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
5. Severe complication (heart disease, cirrhosis, diabetes)
6. Myocardial infarction within 3 months
7. Active synchronous or metachronous malignancy, excluding intramucosal carcinoma
8. Pregnant or lactation women, or women with known or suspected pregnancy
9. Symptomatic brain metastasis
10. history of severe drug allergy
11. Grade 2 or higher peripheral sensory neuropathy
12. Impossible to implant the central venous port
13.Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6972-1181
Email ioka-ta@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ioka
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Division of Hepatobiliary and Pancreatic Oncology
Zip code
Address 3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL 06-6972-1181
Homepage URL
Email ioka-ta@mc.pref.osaka.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Division of Hepatobiliary and Pancreatic Oncology
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 18 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 Completed
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 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 03 Month 18 Day
Last modified on
2016 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024550

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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