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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024088
Receipt No. R000027721
Scientific Title Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction
Date of disclosure of the study information 2016/09/17
Last modified on 2016/09/16

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Basic information
Public title Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction
Acronym Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction
Scientific Title Phase I trial of Nabpaclitaxel combinated radiotherapy for adenocarcinoma of the esophago-gastric junction
Scientific Title:Acronym 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
1st name
Middle name
Last name Masakazu Yamamoto
Organization Tokyo Women's Medical University
Division name Department of Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Kosuke Narumiya
Organization Tokyo Women's Medical University
Division name Department of Gastroenterological Surgery
Zip code
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)

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
2016 Year 09 Month 17 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 05 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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