UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction
Title of the study (Brief title)	Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction
Region	Japan

Condition
Condition	Adenocarcinoma of esophago-gastric junction
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of maximum tolerated dose and recommended dose
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Evaluation of maximum tolerated dose and recommended dose
Key secondary outcomes	Evaluation of Toxicity

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	Protocol of Naqbpacritaxel 120mg/m2~260mg/m2 tri-weekly with radiotherapy 1.8Gy/day (Total 39.6Gy)
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)Male and Femae who is More than 20 years Less than 80 years 2)Resectable Adenocarcinoma of esophago-gastric junction Stage2 or Stage3 3)Without metastasis of organs 4)Within 4weeks diagnosis using by GI or CT of Adenocarcinoma of esophago-gastric junction 5)Performance Status(ECOG)is 0or1 6)Without neoadjyuvant therapy 7)It is possible to perform chemo-radiotherapy before operation 8)The cases which meet criteria as follow1)White blood cell:more than 3,000/mm3 2)The number of neutrophil:more than1,500/mm3 3)The number of neutrophil:more than75,000/mm3 4)The amount of hemoglobin:more than9.0g/dl 5)AST or ALT is less than two point five times standard level in our institute 6)Creatinin is less than 1.5mg/dl 7)Neuropathy level is less than Grade 2 8)Total bililubin is less than 1.5mg/dL 9)Infomed consent is obtained
Key exclusion criteria	1)Nobody performe nabpaclitaxcel before 2)Nobody use blood protacts within 2weeks3)Without drug hypersensitivity 4)Neuropathy level is more than Grade2 5)the patients who have another cancer in the time of entry. 6)With severe complication 7)With infection or chronic inflametory disease 8)Patient use the steroid 9)The patient is pregnancy 10)Male whose partner is pregnancy is possibility from now. 11)It is difficult to decide to take part in this trial with Mentaldisease 12)Docters decides patients are unsuitable for this study.
Target sample size	24

Research contact person
Name of lead principal investigator	Masakazu Yamamoto
Organization	Tokyo Women's Medical University
Division name	Department of Gastroenterological Surgery
Address	8-1 Kawata-cho Shinjyuku-ku Tokyo Japan
TEL	03-3353-8111
Email	yamamoto@ige.twmu.ac.jp

Public contact
Name of contact person	Kosuke Narumiya
Organization	Tokyo Women's Medical University
Division name	Department of Gastroenterological Surgery
Address	8-1 Kawata-cho Shinjyuku-ku Tokyo Japan
TEL	03-3353-8111
Homepage URL
Email	narumiya@ige.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 17 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 19 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	2016 Year 09 Month 16 Day
Last modified on	2016 Year 09 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027721