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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023515
Receipt No. R000027075
Scientific Title A combination therapy of Ramucirumab and Paclitazel as second-line treatment for elderly gastric cancer patients: A exploratory phase II research
Date of disclosure of the study information 2016/12/01
Last modified on 2016/08/06

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Basic information
Public title A combination therapy of Ramucirumab and Paclitazel as second-line treatment for elderly gastric cancer patients: A exploratory phase II research
Acronym A combination therapy of Ramucirumab and Paclitazel for elderly gastric cancer patients
Scientific Title A combination therapy of Ramucirumab and Paclitazel as second-line treatment for elderly gastric cancer patients: A exploratory phase II research
Scientific Title:Acronym A combination therapy of Ramucirumab and Paclitazel for elderly gastric cancer patients
Region
Japan

Condition
Condition advanced gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the feasibility of combination therapy of ramucirumab and paclitaxel as second-line treatment for elderly patients with advanced gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Toxicity
Key secondary outcomes Response rate, PFS, OS

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
75 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Histrogically proven adenocarcinoma
2. Advanced gastric cancer
3. Failure after first-line treatment
4. No massive ascites
5. No cerebrovascular disease
6. Possible oral intake
7. PS: 0 or 1
8. No lethal disfunction of the major organs
9. who gave informed consent
Key exclusion criteria 1. Unconrollable DM
2. VTE
3. MoI
4. Cerebrovascular disease
5. No GI tract bleeding or perforation
6. Uncontrollable hypertension
7. Inappropriate patient for study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunisaki Chikara
Organization Medical Center, Yokohama City University
Division name Dept. of Surg., Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama
TEL 045-261-5656
Email s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunisaki Chikara
Organization Medical Center, Yokohama City University
Division name Dept. of Surg., Gastroenterological Center
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama
TEL 045-261-5656
Homepage URL
Email s0714@med.yokohama-cu.ac.jp

Sponsor
Institute Dept. of Surg., Gastroenterological Center, Medical Center, Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City 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 12 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 Preinitiation
Date of protocol fixation
2016 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 08 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The protcol will be continued until PD or uncontrollable toxicity will be confirmed. Subsequently, the feasibility will be confirmed.

Management information
Registered date
2016 Year 08 Month 06 Day
Last modified on
2016 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027075

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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