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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022221
Receipt No. 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

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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
Email 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
Email t-oka@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025592

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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