UMIN-CTR Clinical Trial

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 Chikara Middle name Last name Kunisaki
Organization	Medical Center, Yokohama City University
Division name	Dept. of Surg., Gastroenterological Center
Zip code	232-0024
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 Chikara Middle name Last name Kunisaki
Organization	Medical Center, Yokohama City University
Division name	Dept. of Surg., Gastroenterological Center
Zip code	232-0024
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	Y-NEXT
Address	1-1-1 Fukuura, Kanazawa-ku, Yokohama
Tel	0453707627
Email	rinri@yokohama-cu.ac.jp

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	2020 Year 08 Month 20 Day

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