UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Title of the study (Brief title)	Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy
Region	Japan

Condition
Condition	Advanced Gastric Cancer
Classification by specialty	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	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Incidence and grade of Adverse Event, Response Rate,Over all Survival

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(80mg/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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who provided written informed consent. 2.Patients with gastric cancer by histological or cytological examination. 3.Patients with prior on chemothrapy. (including recurrence within 6 months after last adjuvant chemotherapy) 4.More than 2 weeks last chemotherapy 5.ECOG performance status<=2 6.Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration WBC count more than 3,000/mm3 Neutrophils count more than 1,200/mm3 Hemoglobin more than 8.0 g/dl Platelet count more than 75,000/mm3 Serum bilirubin level less than 2.0mg/dl AST and ALT less than 100 IU/l 20 years old or more Patients expected to survive for 90 more than days
Key exclusion criteria	1.History of serious drug hypersensitivity 2.Any other serious illness or medical conditions including interstitial pneumonia or pulmonary fibrosis, renal failure, liver failure,cerebrovascular disordar or Uncontrolled diabates 3.Active infection or fever suspicious of infection. 4.Surgical procedure within 4 weeks before registration 5.Uncontrolled unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia 6.History of mental disorder, central nerve disorder. 7.Pregnant women, nursing mothers 8.Patients who were considered by the primary care physician to be inappropriate for this trial
Target sample size	21

Research contact person
Name of lead principal investigator	Ryoji Fukushima
Organization	Teikyo University School of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo
TEL	03-3964-1231
Email	ryojif@med.teikyo-u.ac.jp

Public contact
Name of contact person	Ryoji Fukushima
Organization	Teikyo University School of Medicine
Division name	Surgery
Address	2-11-1 Kaga, Itabashi-ku Tokyo
TEL	03-3964-1231
Homepage URL
Email	ryojif@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine
Institute
Department

Funding Source
Organization	Teikyo University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	帝京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 20 Day
Anticipated trial start date	2013 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 27 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013825