UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014039 |
|---|---|
| Receipt number | R000016341 |
| Scientific Title | Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II |
| Date of disclosure of the study information | 2014/05/22 |
| Last modified on | 2014/06/18 17:23:15 |
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Basic information
Public title
Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II
Acronym
CFLAP study
Scientific Title
Converison therapy of FOLFIRINOX in patients with unresectable locally advanced pancreatic cancer: A phase II
Scientific Title:Acronym
CFLAP study
Region
| Japan |
Condition
Condition
Unresectable locally advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the resection post FOLFIRINOX for unresectable locally advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
the ratio of R0 resection
Key secondary outcomes
the ratio of R0+R1 resection, Response rate, Progression Free Survival: PFS, Overall Survival: OS, Safety
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
| Maneuver |
Interventions/Control_1
1 course:14 days. FOLFIRINOX;L-OHP, l-LV, CPT-11 and 5-FU on day1
Conversion therapy will be done with resectable cancer.
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)Invasive pancreatic ductal carcinoma histologically confirmed
2)None of metastatic lesions by laparoscopy.
3)Patients with no previous chemotherapy for pancreatic cancer.
4)ECOG Perfomance status must be 0 or 1.
5)Patients must be >=20 years old and <=75 years old at the time of consent.
6)Life Expectancy must be >=8 weeks.
7)Having of measurable lesions must be required(RECIST v1.1).
8)The following criteria must be satisfied for primary lesion(NCCN guideline v1.2014).
a)Cancerous stricture of superior mesentric artery(SMA) or celiac artery
b)Occlusion of superior mesentric vein(SMV) or portal vein(PV) cannot to be reconstructed
c)Cancerous invasion or cancerous stricture of Paraaorta
9)The following criteria must be satisfied in laboratory tests conducted within 7 days before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untreated within 7days before enrollment.
-White blood cell count >=3,500 /mm3 ,<=12,000/mm3
-Neutrophil count >=2,000 /mm3
-Hemoglobin >= 9.0 g/dL
-Platelet count >=100,000 /mm3
-Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
-AST <=150 IU/L
-ALT <=150 IU/L
-Serum Creatinine <=1.5 mg/dL
10)Patient must have signed the consent form.
Key exclusion criteria
1)Severe drug hypersensitivity
2)Severe dysesthesia with functional disorder
3)homozygote(UGT1A1 *6/*6, UGT1A1 *28/*28) or heterozygote(UGT1A1 *6/*28)
4)Prior treatment(chemotherapy or radiation)
5)Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 5 year) except carcinoma in situ or intramucosal cancer
6)Infections that needs systemic treatment.
7)Pregnant females or being suspected, or nursing mothers.
8)Severe nervous disorder or mental disorder.
9)Transufusion, Blood products and G-CSF tried within 7days before enrollment.
10)Much pleural effusion, ascites fluid, pericardial fluid.
11)Jaundice
12)Congestive heart failure, symptomatic cerebrovascular accident, uncontrolable arrhythmia, and history of myocardial infarction in 12 months
13)Severe interstitial pneumonia or pulmonary fibrosis.
14)Diarrhea(to bring troubles in patients who have stoma)
15)Active peptic ulcer, paresis of intestine and ileus
16)Uncontrolled diabetes mellitus(DM) or DM with nervous disorder.
17)Need continuous medication of atazanavir sulfate.
The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ryutaro mori |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City, Kanagawa Pref Japan
TEL
045-787-2650
ryutaromori@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ryutaro mori |
Organization
Yokohama City University
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City, Kanagawa Pref Japan
TEL
045-787-2650
Homepage URL
ryutaromori@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Yokohama City University
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
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 22 | 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
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2014 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016341
