UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007368 |
|---|---|
| Receipt number | R000008675 |
| Scientific Title | Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old |
| Date of disclosure of the study information | 2012/02/23 |
| Last modified on | 2018/03/08 08:46:31 |
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Basic information
Public title
Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Acronym
JACCRO GC-06
Scientific Title
Phase II study of TS-1+Trastuzumab in HER2-positive advanced gastric cancer patients more than 65 years old
Scientific Title:Acronym
JACCRO GC-06
Region
| Japan |
Condition
Condition
HER2-positive advanced gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation ofr the efficacy and safety of S-1 plus trastuzumab for elderly (more than 65 years old) HER2-positive advanced gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate (RR)
Key secondary outcomes
Overall survival(OS)
Progression free survaval(PFS)
Time to treatment faulure(TTF)
Safety
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
Drug:TS-1 and Trastuzumab
TS-1:80mg/m2/dat on Day 1-28
Trastuzumab:6mg/kg/body on Day 1 and Day 22 (first time: 8mg/kg/body)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically confirmed unresectable or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction.
2) Patients who have measurable region defined by RECIST version 1.1.
3) Patients who have HER2-positive cancer confirmed with IHC and /or FISH (IHC 3+ or IHC2+ and FISH positive)
4) More than 65 years old.
5) Performance status (ECOG scale) 0, 1 or 2.
6) No prior chemotherapy or radiotherapy for gastric cancer.
7) Adequate baseline organ and marrow function as defined below:
1. Leukocyte : 3,500-12,000/mm3
2. Absolute neutrophil count : >= 2,000/mm3
3. Platelets : >= 100,000/mm3
4. Hemoglobin : >=9.0g/dL
5. AST : < 100IU/L
6. ALT : < 100IU/L
7. Total bilirubin : < 1.5mg/dL
8. Serum creatinine : <= 1.2mg/dL
9. Creatinine clearance : >= 50ml/min
8) Patients with left ventricular ejection fraction of at leaset 50% on MUGA scan or echocardiography done within 21days before enrollment.
9) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment
10) Patients able to take orally
11)Life expectancy of greater than 3 months
12) Patients should sign a written informed consent.
Key exclusion criteria
1) Scond primary malignancy (except adequately treated basal cell carcinoma treated more than 5 years ago without recurrence)
2) Severe ascites and / or pleural effusion
3) Patients with brain metastasis
4) Patients with fresh bleeding from gastric cancer and / or the digestive tract
5) Patients with active infection (> 38C)
6) Patients have active hepatitis type B
7) Patients with a previous history of congestive heart failure
8) Unstable angina requiring medication
9) Patients with a previous history of transmural infarct
10) Uncontrolled hypertension
11) Severe heart valve diseases
12) Hi-risk uncontrolled arrhythmias
13) Serious complication as followings; interstitial pneumonia; pulmonary fibrosis; heartfailure; renal failure; hepatic failure; uncontrolled diabetes mellitus
14) Patients with resting dyspnea
15) Patients with diarrhea (4 or more times per day or watery diarrhea) 16) Patients who are contraindicated to TS-1 and Trastuzumab
17) Hypersensitivity to have a history TS-1 and / or Trastuzumab
18) Patients who are received systemic continuous admnistration of flucytosine.
19) Patients who are recieving systemic continuous administration of phenytoin or warfarin
20) Patients who are received systemic administration of corticosteroid for a long time or with high doses
21) Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. Men who want their partners to become pregnant.
22) Any patinets judged by the investigator to be unfit to perticipate in the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Takiuchi |
Organization
Osaka Medical College
Division name
Cancer Chemotherapy Center
Zip code
Address
2-7 Daigaku-cho, Takatsuki, Osaka, 569-8181
TEL
03-3293-1711
masashi.fujii@gioncology.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Secretariat
Zip code
Address
1-14-5 Ginza, Chuo-ku, Tokyo
TEL
03-5579-9882
Homepage URL
gc06.dc@jaccro.or.jp
Sponsor or person
Institute
Japna Clinical Cancer Research Organizetion
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪医科大学附属病院（大阪府）ほか、JACCRO参加施設
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008675
