UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016877 |
|---|---|
| Receipt number | R000019595 |
| Scientific Title | A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2021/03/31 22:10:33 |
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Basic information
Public title
A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function
Acronym
A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function
Scientific Title
A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function
Scientific Title:Acronym
A phase I/II trial of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function
Region
| Japan |
Condition
Condition
Patients with resectable pancreatic cancer and impaired renal function
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of preoperative chemoradiotherapy with gemcitabine in patients with pancreatic cancer and impaired renal function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I: Safety
Phase II: Pathological response
Key secondary outcomes
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
Preoperative chemoradiotherapy with gemcitabine
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Histologically proven pancreatic adenocarcinoma
(2) Age between 20 and 80 years
(3) ECOG performance status of 0 or 1
(4) Creatinine clearance <60 ml/min (excluding dialysis patients)
(5) Surgically resectable
(6) Life Expectancy must be >=6 months
(7) Adequate hematologic, hepatic and respiratory function
(8) Interval of at least 4 weeks between prior treatment and start of present study
(9) Written informed consent
Key exclusion criteria
(1) Unresectable pancreatic cancer
(2) Dialysis patients
(3)Presence or past history of interstitial pneumonia or pulmonary fibrosis or possible
(4) Active infections (excluding viral hepatitis)
(5) Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus
(6) Presence of pleural effusion or ascites requiring drainage
(7) Presence of metastasis in central nervous system
(8) Active double cancer except carcinoma in situ or intramucosal cancer (synchronous double cancer or asynchronous double cancer with disease-free duration to be within 3 years)
(9) Pregnant females or nursing mothers who can not stop lactation. Patients or partners, who don't attempt to doing contraception during the study period.
(10) Severe mental disorder
(11) Severe drug hypersensitivity
(12) As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Eguchi |
Organization
Osaka University
Division name
Gastroenterological Surgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3251
Homepage URL
heguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Clinical Study Group of Osaka University
Institute
Department
Personal name
Funding Source
Organization
None (Self-funding)
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
Clinical Study Group of Osaka University
Address
2-2 Yamadaoka, Suita, Osaka, Japan
Tel
06-6879-3251
heguchi@gesurg.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00280-019-04005-y
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00280-019-04005-y
Number of participants that the trial has enrolled
8
Results
Refer to paper
Results date posted
| 2021 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Refer to paper
Date of the first journal publication of results
Baseline Characteristics
Refer to paper
Participant flow
Refer to paper
Adverse events
Refer to paper
Outcome measures
Refer to paper
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | 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
| 2015 | Year | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019595
