UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021728
Receipt number 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 20:38:36

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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