UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000010869|
|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|
|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)|
|Condition||HER2 positive gastric cancer|
|Classification by specialty||
|Classification by malignancy||Malignancy|
|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 objectives -Others|
|Developmental phase||Phase II|
|Primary outcomes||Overall response rate (ORR)|
|Key secondary outcomes|
|Basic design||Single arm|
|Blinding||Open -no one is blinded|
|No. of arms||1|
|Purpose of intervention||Treatment|
|Type of intervention||
|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.
|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||
|Organization||Institute of Development, Aging and Cancer, Tohoku University|
|Division name||Department of Clinical Oncology|
|Address||4-1 Seiryo-machi, Aoba-ku, Sendai|
|Name of contact person||
|Organization||Tohoku Clinical Oncoogy, Research and Education Society(T-CORE)|
|Division name||Administration Office|
|Address||4-1 Seiryo-machi, Aoba-ku, Sendai, 9808575, Japan|
|Institute||Tohoku Clinical Oncology, Research and Education Society(T-CORE)|
|Organization||Tohoku Clinical Oncology, Research and Education Society(T-CORE)|
|Category of Funding Organization||Non profit foundation|
|Nationality of Funding Organization|
|Other related organizations|
|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|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled||27|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB||
|Anticipated trial start date||
|Last follow-up date||
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
|Registered date||File name|