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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010869
Receipt No. R000012560
Scientific Title Phase II trial of trasutuzumab plus docetaxel for previous trastuzumab treated unresectable or recurrent HER2 positive gastric cancer (T-CORE1203)
Date of disclosure of the study information 2013/06/06
Last modified on 2020/07/07

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Basic information
Public title Phase II trial of trasutuzumab plus docetaxel for previous trastuzumab treated unresectable or recurrent HER2 positive gastric cancer (T-CORE1203)
Acronym Phase II trial of trasutuzumab plus docetaxel for previous trastuzumab treated unresectable or recurrent HER2 positive gastric cancer (T-CORE1203)
Scientific Title Phase II trial of trasutuzumab plus docetaxel for previous trastuzumab treated unresectable or recurrent HER2 positive gastric cancer (T-CORE1203)
Scientific Title:Acronym Phase II trial of trasutuzumab plus docetaxel for previous trastuzumab treated unresectable or recurrent HER2 positive gastric cancer (T-CORE1203)
Region
Japan

Condition
Condition HER2 positive gastric cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary endpoint is to evaluate overall response rate (ORR) of trasutuzumab plus docetaxel in patients with previously trasutuzumab treated unresectable/recurrent HER2 positive gastric cancer. Secondary endpoint is to estimate progression free survival, 6 month survival rate, overall survival and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Overall response rate (ORR)
Key secondary outcomes

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 Trastuzumab is given by intravenous
infusion at a dose of 8 mg/kg on day 1 of the fi rst cycle, followed by 6 mg/kg every 3 weeks. Docetaxel is given by intravenous infusion at a dose of 60 mg/m2, followed by trasutuzumab. The treatment was continued until the criteria to discontinue the trial were met.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient with unresectable or recurrence gastric cancer which is pathologically comformed adenocarcinoma.
2. HER2 positive is confirmed from primary or metastatic tumor (HER2 positive is defined as HER2 (3+) by IHC or HER2 (2+) and FISH positive).
3. Patient who has recieved trasutuzumab containing treatment as first line and is refractory to trasutuzumab containig regimen.
4. One or more measurable lesions based on the RECIST (ver 1.1) and progressive disease after trasutuzumab containing treatment as first line are confirmed by CT or MRI before registration within 28 days.
5. At the time of starting the treatment, at least 28 days are passed since the last treatment of 1st line therapy.
6. No prior therapy of docetaxel containing regimen.
7. Age 20 years old or elder.
8. An Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 - 2
9. Patient who has normal cardiac function : LVEF lower limit or more than 50% was confirmed by echocardiography or MUGA scan within 3 month before registration.
10. Written informed concent was obtained from the patients.
11. Adequate organ function defined by the following data within 14 days before registration. No transfusion and administration of hematopoietic factor are allowed within 2 weeks before examination:
(1) WBC: 3,000-12,000/mm3
(2) Neutrophiles: 1,500/mm3 or more
(3) Platelets: 75,000/mm3 or more
(4) Hb: 8.0 g/dl or more
(5) total bilirubin: upper limit or less than 2.0 mg/dl
(6) AST(GOT) and ALT(GPT): 100 IU/L or less (in case with metastatic liver tumor, 200 IU/L or less)
(7) serum creatinine: upper limit or less than 1.5mg/dl
Key exclusion criteria 1. Patient who has active double cancer (excluding carcinoma in situ and skin cancer which were cured, and GI tract cancer in which curable operation was carried out by EMR)
2. Patient who has severe or uncontrolled complication (infection, pulmonary fibrosis, paralytic intestine, bowel obstruction, uncontrolled diabetes mellitus, liver cirrhosis, uncontrolled hypertension, myocardiac infarction or unstable angina within 1 year before registration).
3.Active (significant or uncontrolled) bleeding from GI tract.
4.Patient who needs drainage of peritoneal, pleural or pericardial effusion.
5.Contraindication against trasutuzumab and docetaxel.
6.Women who is pregnancy, possible pregnancy or lactation and patients who wish their partner to become pregnant.
7.Attending physician determines that the case was inappropriate as the subject of this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chikashi
Middle name
Last name Ishioka
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Clinical Oncology
Zip code 980-8575
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 Masanobu
Middle name
Last name Takahashi
Organization Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)
Division name Administration Office
Zip code 980-8575
Address 4-1 Seiryo-machi, Aoba-ku, Sendai, 9808575, Japan
TEL 022-717-8599
Homepage URL http://www.t-core.jp/
Email tcore-admin@umin.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 Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization MHLW Certified Clinical Research Review Board, Tohoku University
Address 2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan
Tel 022-718-0461
Email office@nrs.hosp.tohoku.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
2013 Year 06 Month 06 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 27
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 Completed
Date of protocol fixation
2012 Year 12 Month 21 Day
Date of IRB
2013 Year 03 Month 26 Day
Anticipated trial start date
2015 Year 12 Month 01 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

Management information
Registered date
2013 Year 06 Month 04 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012560

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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