UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022221 |
|---|---|
| Receipt number | R000025592 |
| Scientific Title | Feasibility study for 2nd line combination chemotherapy of Nab-paclitaxel with Ramucirumab for inoperable advanced recurrent gastric cancer. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2019/05/09 12:08:34 |
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Basic information
Public title
Feasibility study for 2nd line combination chemotherapy of Nab-paclitaxel with Ramucirumab for inoperable advanced recurrent gastric cancer.
Acronym
Feasibility study for 2nd line combination chemotherapy of Nab-PTX with Ramucirumab for gastric cancer.
Scientific Title
Feasibility study for 2nd line combination chemotherapy of Nab-paclitaxel with Ramucirumab for inoperable advanced recurrent gastric cancer.
Scientific Title:Acronym
Feasibility study for 2nd line combination chemotherapy of Nab-PTX with Ramucirumab for gastric cancer.
Region
| Japan |
Condition
Condition
Inoperable advanced recurrent gastric cancer (2nd line chemotherapy).
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accomplishment rate of 3 cycle themotherapies and the efficacy and the safety of Nab-paclitaxel and Ramucirumab combination chemotherapy as a second line chemotherapy for the patients with inoperative advanced or recurrent gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
the accomplishment rate of 3 cycle chemotherapies
Key secondary outcomes
Occurence frequency and degree of adverse event
Disease Control Rate: DCR
Response rate: RR
Overall survival: OS
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Nab-PTX:260mg/m2 (day1)
to be repeated every 3 weeks until meeting the withdrawal criteria.
Ramucirumab:8mg/m2 (day1, 15)
to be repeated every 2 weeks until meeting the withdrawal criteria.
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. Histological confirmed unresectable advanced or recurrent gastric cancer
2. Prior chemotherapy with more than two weeks
3. ECOG performance status 0-2
4. Age over 20 years old
5. 1st line chemotherapy already have done
6. Cases with adequately maintained organ functions and fullfilling the following conditions within 2 weeks before registration.
leukocyte count >=3000/mm3 and <= 12000/mm3
neutrophil count >= 1,500/mm3
platelet count >= 100,000/mm3
hemoglobin level >= 8.5g/dL
total bilirbin <= 1.5mg/dL
(<=2.5mg/dL with constitutional jaundice)
AST and ALT <= 100IU/L, or AST and ALT <= 200IU/L with primary disease
serum creatinine <= 1.5mg/dL
peripheral neuropaty <= grade 1
7.Cases expected to survive for 90 days or more
8. Written informed consent
Key exclusion criteria
1. History of serious allergic drug reaction
2. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma
3. history of paclitaxel administration
4. serious complications (pulmonary fibrosis or interstitial pneumonitis, renal failure, liver failure, cerebrovascular accident, ulcer using blood infusion, uncontolable diabetes mellitus)
5. serious infection
6. Massive pericardial effusion, pleural effusion or ascites
7. massive bone metastases
8. brain metastasis including suspicious state
9. Pregnant or lactating female
10. severe disorder of electrocardiogram
11. serious mental disorder
12. Judged inappropriate by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gatroenterology and Hepatology
Zip code
Address
465 Kaji-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Okayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gatroenterology and Hepatology
Zip code
Address
465 Kaji-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
t-oka@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
| 2016 | Year | 07 | Month | 01 | 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
| 2016 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2019 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025592
