UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013105 |
|---|---|
| Receipt number | R000015281 |
| Scientific Title | Phase 2 trial of weekly Nab paclitaxel for advanced gastric cancer patients with prior chemotherapy |
| Date of disclosure of the study information | 2014/02/10 |
| Last modified on | 2021/08/13 17:43:34 |
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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
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
hideaki.shimada@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015281
