UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010869 |
|---|---|
| Receipt number | 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 15:22:31 |
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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
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/
tcore-admin@umin.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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012560
