UMIN-CTR Clinical Trial

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
Email	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
Email	heguchi@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Clinical Study Group of Osaka University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019595