UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014079 |
|---|---|
| Receipt number | R000016387 |
| Scientific Title | Pilot study of FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer |
| Date of disclosure of the study information | 2014/05/27 |
| Last modified on | 2018/05/31 15:14:30 |
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Basic information
Public title
Pilot study of FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer
Acronym
FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer
Scientific Title
Pilot study of FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer
Scientific Title:Acronym
FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer
Region
| Japan |
Condition
Condition
locally advanced and metastatic pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of FOLFOX and FOLFIRI sequential chemotherapy for locally advanced and metastatic pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival (OS)
Key secondary outcomes
Progression free survival (PFS), Response Rate (RR), Incidence of grade 3/4 adverse events
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
FOLFIRI therapy (1cycle/2week) LV; 200mg/m2 div day1, CPT-11; 150mg/m2 div day1, 5-FU bolus; 400mg/m2 div day1, 5-FU 46h infusion; 2400mg/m2 div day1 46h FOLFOX therapy (1cycle/2week) LV; 200mg/m2 div day1, L-OHP; 85mg/m2 div day1, 5-FU bolus; 400mg/m2 div day1, 5-FU 46h infusion; 2400mg/m2 div day1 46h
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma.
2) unresectable locally advanced or metastatic pancreatic cancer (a definition; NCCN guide line Version 1.2014)
3) Age upper 20
4) PS(ECOG) between 0 and 2
5) No previous radiation, hormone or chemotherapy for pancreatic cancer (except for adjuvant chemotherapy)
6) with a good condition of important organs within 14 days of registration
7) expected more than 90 days survival
8) written informed consent to participate in this study
Key exclusion criteria
1) with pulmonary fibrosis or interstitial pneumonia which can be detected from X-ray incontrovertibly or has clinical symptom
2) with severe diarrhea within 3 days before entry
3) with other severe diseases (heart failure, renal disfunction, liver disfunction, intestinal paralysis, ileus, uncontrolled DM)
4) patients whom administered Flucitosine or Fenitoin or Warfarin
5) with active double cancers whose disease free period is shorter than 5 years, Carcinoma in situ can be excluded.
6) with infectious disease which needs therapy
7) with body temperature over 38 degrees Celsius
8) women who are pregnant or expect to be pregnant, or nursing female
9) patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms
10) general administration of steroids
11) with indication of FOLFIRINOX therapy
12) in the case of receiving adjuvant chemotherapy, recurrence within 180 days from the last administration of adjuvant chemotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Goto |
Organization
Osaka Medical College Hospital
Division name
Cancer Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1221
in2030@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Goto |
Organization
Osaka Medical College Hospital
Division name
Cancer Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki-City, Osaka, Japan
TEL
072-683-1221
Homepage URL
in2030@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
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
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
大阪医科大学附属病院（大阪府）
Osaka Medical College Hospital (Osaka Prefecture)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 27 | 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 | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
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 | 27 | Day |
Last modified on
| 2018 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016387
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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