UMIN-CTR Clinical Trial

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

HER2 positive gastric cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall response rate (ORR)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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