UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501)
Title of the study (Brief title)	Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with gastric cancer (T-CORE1501)
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and toxicity of ramucirumab plus paclitaxel therapy for elderly patients with unresectable or metastatic gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression-free survival
Key secondary outcomes	OS. ORR, TTF, DCR, toxicity, correlation between CGA screening score and efficacy/toxicity

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	Ramucirumab 8 mg/kg day 1, 15 Paclitaxel 80 mg/m2 day 1, 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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients are required to fulfill the following criteria for eligibility. 1) histologically confirmed as adenocarcinoma of the stomach 2) One or more evaluable lesions confirmed by CT or other imaging within 28 days before the registration. 3) ECOG performace status: 0-2. 4) Received only one previous chemotherapeutic regimen which is 5-FU-based (inluding patients who had recurrence during or within 24 weeks after adjuvant chemotherapy) 5) Estimated to survive for three months or more since registration. 6) Written informed consent. 7) Age 70 or above. 8) Fulfill the following hematological and biochemical data obtained in the most recent blood and urine tests. Neutrophils >= 1,500 /mm3, platelets >= 100,000 /mm3, hemoglobin >= 8.0 g/dl, AST =< 100 IU/l, ALT =< 100 IU/l, total bilirubin =< 1.5 g/dl, and creatinie =< 1.5 in blood test, and urine protein <= 1+ or 2 g/day. Patients should not receive transfusion or granulocyte colony stimulating factor within 14 days before the blood test. 9) Determined to be able to receive the study protocol by the responsible researcher or contributing researchers of this study.
Key exclusion criteria	Patients who fulfill the following criteria for exclusion are excluded. 1) Received taxane-based regimen. 2) Synchronous double cancer or past history of other cancer within 5 years, except curable carcinoma in situ and skin cancer. 3) Active infection and inflammation. 4) Active hepatitis. 5) Current or past history within 1 year of serious heart disease that requires hospitalization 6) Serious complications or severe complications that require hospitalization for therapy, such as gastrointestinal paresthesia, bowel obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable hypertension, diabetes mellitus, renal dysfunction, liver dysfunction, and hepatic cirrhosis. 7) Active gastrointestinal bleeding. 8) Gastrointestinal perforation or histula, artelial embolism within 6 months or venous thromboembolism within 3 months before registration. 9) Receiving medications with psychotropic drugs for mental disorders, or having mental disorders that require medications with psychotropic drugs. 10) Grade 2 or more neuropathy. 11) Effusion that requires drainage. 12) Determined to be inappropriate to enter the study by the responsible researcher or contributing researchers, for any other reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	Chikashi Ishioka
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Clinical Oncology
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-8543
Email	chikashi@tohoku.ac.jp

Public contact
Name of contact person	Hideki Shimodaira
Organization	Tohoku Clinical Oncology Research and Education Societ (T-CORE)
Division name	Office
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-8599
Homepage URL
Email	hideki.shimodaira.c4@tohoku.ac.jp

Sponsor
Institute	Tohoku Clinical Oncology Research and Education Society (T-CORE)
Institute
Department

Funding Source
Organization	Tohoku Clinical Oncology Research and Education Society (T-CORE)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 30 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2017 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025058