UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024088 |
|---|---|
| Receipt number | 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 19:31:55 |
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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
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
narumiya@ige.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027721
