UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021728
Receipt No. R000025058
Scientific Title Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501)
Date of disclosure of the study information 2016/04/01
Last modified on 2017/04/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501)
Acronym Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with gastric cancer (T-CORE1501)
Scientific Title Phase II study of ramucirumab plus paclitaxel therapy for elderly patients with non-resectable or metastatic gastric cancer (T-CORE1501)
Scientific Title:Acronym 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
1st name
Middle name
Last name Chikashi Ishioka
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Clinical Oncology
Zip code
Address 4-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8543
Email chikashi@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Shimodaira
Organization Tohoku Clinical Oncology Research and Education Societ (T-CORE)
Division name Office
Zip code
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)

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 04 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
Date of protocol fixation
2016 Year 03 Month 30 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.