UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006975 |
|---|---|
| Receipt number | R000008025 |
| Scientific Title | CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study- |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2013/01/06 00:37:15 |
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Basic information
Public title
CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study-
Acronym
CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study-
Scientific Title
CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study-
Scientific Title:Acronym
CPT-11 or weekly PTX and Trastuzumab for previously treated HER2 positive advanced gastric cancer -Phase II study-
Region
| Japan |
Condition
Condition
previously treated HER2 positive advanced gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy and safety of CPT-11 or weekly PTX plus trastuzumab for previously treated HER2 positive advanced gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
PFS: Progression Free Survival
Key secondary outcomes
ORR:Overall Response Rate
DCR:Disease Control Rate
OS:Overall Survival
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CPT-11 / Trastuzumab(CPT-11 150 mg/kg q2w and Trastuzumab 8 or 6 mg/kg q3w)
or
PTX / Trastuzumab(PTX 80 mg/kg qw and Trastuzumab 8 or 6 mg/kg q3w)
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) Non-curative resected or recurrent gastric cancer histologically proven adenocarcinoma (included EGJ cancer)
(2) Positive HER2 status(IHC3+ or IHC2+/FISH+)
(3) Written informed conscent to receive this chemotherapy.
(4) 20 years old or more than 20 years old.
(5) Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
(6) Life expectancy of at least 3 months after registration.
(7) Case which has lesions to be evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline.
(8) Adequate organ function as follows:
1. WBC count 3,500-12,000/mm3
2. Neutrophils count more than 1,500/mm3
3. Platelet count more than 100,000/mm3
4. Hemoglobin more than 8.0 g/dl
5. Serum bilirubin level less than 1.5 mg/dl
6. Ast and ALT less than 100 IU/l
7. Serum creatinine level less than 1.2 mg/dl
8. Creatinine clearance more than 50mL/min
9. LVEF more than 50%
(9)More than one previous chemotherapy(except adjuvant chemotherapy).
(10)No previous CPT-11 history.
Key exclusion criteria
(1) Forbidden case to use CPT-11/PTX and Trastuzumab.
(2) Baseline left ventricular ejection fraction (LVEF) is <50% measured by echocardiography or MUGA scan.
(3) In the UGT1A1 allele,
UGT1A1(*)6/(*)6 genotype or UGT1A1(*)28/(*)28 genotype
UGT1A1(*)28/(*)6 genotype
(4) R1 operation(histlogically positive PM, OM, LM, VM).
(5) Infection or inflammatory case.
(6) Severe heart disease.
(7) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc.
(8) Severe ascites and/or pleural effusion.
(9) Multiple bone metastasis.
(10) Clinical suspicion or previous history of metastasis to brain or meninges.
(11) Difficulty to join the trial due to psychosis or psychotic symptoms or central nervous system damage.
(12)Complicated other active cancer.
(13)patient who want to be pregnant and /or pregnant woman.
(14)Intend to make pregnant.
(15)Active hepatitis type HBs positive.
(16)No previous treatment(except adjuvant chemotherapy).
(17)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Miura |
Organization
Matsue City Hospital
Division name
Gastroenterology
Zip code
Address
32-1, Noshira-cho, Matsue, Shimane, 690-0045, Japan
TEL
0852-60-8000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Miura |
Organization
Matsue City Hospital
Division name
Gastroenterology
Zip code
Address
32-1, Noshira-cho, Matsue, Shimane, 690-0045, Japan
TEL
0852-60-8000
Homepage URL
m.miura@matsue-cityhospital.jp
Sponsor or person
Institute
SGCSG: Shimane Gastroenterological Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
SGCSG: Shimane Gastroenterological Cancer Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 28 | 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
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2013 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008025
