UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Acronym	Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Scientific Title	Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Scientific Title:Acronym	Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Region	Japan

Condition
Condition	advanced advanced for gastric cancer patients with prior chemotherapy
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of weekly Nab paclitaxel advanced advanced for gastric cancer patients with prior chemotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Response Rate Disease Contorol Rate Overall Survival Incidence and grade of Adverse Event,

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	Nab paclitaxel(100mg/m2 day1,8,15) every 4 weeks
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)Patients with gastric cancer by histological or cytological examination. 2)The case that radical operation is enforced 3)Patients with prior on chemothrapy. (including recurrence within 6 months after last adjuvant chemotherapy) 4)20 years old or more 5)ECOG performance status<=2 6)More than 2 weeks last chemotherapy 7)Patients with adequately maintained organ functions and fulfilling the following conditions within 21 days before registration WBC count more than 3,000/mm3 less than , 12,000 /mm3 Neutrophils count more than 1,500/mm3 Hemoglobin more than 8.0 g/dl Platelet count more than 100,000/mm3 Serum bilirubin level less than 1.5mg/dl AST and ALT less than 2.5times 8)Patients who provided written informed consent. 9)Patients expected to survive for 90 more than days
Key exclusion criteria	1)patients previously treated with Nab-paclitaxel,paclitaxel derivative drugs 2)peripheral neuropathy 3)History of serious drug hypersensitivity 4)active synchronous malignancy with longer than 5 year interval period 5)Uncontrolled unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia 6)Any other serious illness or medical conditions including interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure,cerebrovascular disordar or Uncontrolled diabates 7)Active infection or fever suspicious of infection. 8)The case that uses a steroid regularly 9)Much amount of pleural effusion, ascites or cardiac effusion 10)Case having extensive bone metastasis 11)with brain metastasis 12)History of mental disorder, central nerve disorder 13)Pregnant women, nursing mothers 14)Patients who were considered by the primary care physician to be inappropriate for this trial
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jiro Nagao
Organization	Toho University school of Medicine
Division name	Department of Surgery (Ohashi)
Zip code
Address	2-17-6 Ohashi, Meguro-ku, Tokyo
TEL	03-3468-1251
Email	jirojirona@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideaki Shimada
Organization	Toho University school of Medicine
Division name	Division of General and Gastroenterological Surgery, Department of Surgery (Omori)
Zip code
Address	6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL	03-3762-4151
Homepage URL
Email	hideaki.shimada@med.toho-u.ac.jp

Sponsor
Institute	Toho University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
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
Email

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	2014 Year 02 Month 10 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	2013 Year 11 Month 12 Day
Date of IRB	2013 Year 09 Month 19 Day
Anticipated trial start date	2014 Year 02 Month 10 Day
Last follow-up date	2016 Year 04 Month 05 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 02 Month 07 Day
Last modified on	2021 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015281