UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036969 |
|---|---|
| Receipt number | R000041951 |
| Scientific Title | Phase I/II study of S-IROX as second-line therapy after nab-Paclitaxel + Gemcitabine for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2022/12/19 11:45:39 |
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Basic information
Public title
Phase I/II study of S-IROX as second-line therapy after nab-Paclitaxel + Gemcitabine for unresectable pancreatic cancer
Acronym
2nd-line S-IROX Study
Scientific Title
Phase I/II study of S-IROX as second-line therapy after nab-Paclitaxel + Gemcitabine for unresectable pancreatic cancer
Scientific Title:Acronym
2nd-line S-IROX Study
Region
| Japan |
Condition
Condition
The unresectable advanced pancreatic cancer after first-line Nab-Paclitaxel+Gemcitabine failure
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of second-line S-IROX after nab-Paclitaxel and Gemcitabine in inoperable pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Overall survival
Progression free survival
The frequency of occurrence of complication
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
L-OHP:dose escalation
CPT-11:dose escalation
TS-1:fixed dose
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
Histological or cytologically proved pancreatic cancer adenocarcinoma or adenosquamous carcinoma
Second-line chemotherapy for pancreatic cancer after nab-Paclitaxel and Gemcitabine
Age 20-75 years
ECOG Performance Status (PS) 0-1
Meets the following criteria within 14 days before enrollment
absolute neutrophil count <1500/microL, platelet count <75,000/microL, hemoglobin <9g/dl, bilirubin >2.0mg/dl, AST and ALT >150U/l, Creatinine >1.2mg/dl, Creatinine clearance test <50ml/min
Hemotype of UGT1A1 genotype is not including *6/*6, *28/*28, and *6/*28
Without anorexia
Normal ECG
An agreement is provided
Key exclusion criteria
Pulmonary fibrosis or interstitial pneumonia
Watery stool
Infection
Uncontrolled diabetes mellitus
Any serious complication
Pregnancy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Gifu Municipal Hospital
Division name
Department of Gastroenterology
Zip code
500-8513
Address
7-1 Kasima-cho, Gifu city, Gifu
TEL
058-251-1101
mkobdkl@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Gifu Municipal Hospital
Division name
Department of Gastroenterology
Zip code
500-8513
Address
7-1 Kasima-cho, Gifu city, Gifu
TEL
058-251-1101
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Municipal Hospital
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
Gifu Municipal Hospital
Address
7-1 Kasima-cho, Gifu city, Gifu
Tel
058-251-1101
mkobdkl@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 05 | 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
| 2019 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041951
