UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005998 |
|---|---|
| Receipt number | R000007036 |
| Scientific Title | A Phase II study of capecitabine plus cisplatin (plus trastuzumab) for previously untreated advanced gastric cancer. |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2017/08/01 15:47:49 |
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Basic information
Public title
A Phase II study of capecitabine plus cisplatin (plus trastuzumab)
for previously untreated advanced gastric cancer.
Acronym
XP+trastuzumab for advanced gastric cancer
Scientific Title
A Phase II study of capecitabine plus cisplatin (plus trastuzumab)
for previously untreated advanced gastric cancer.
Scientific Title:Acronym
XP+trastuzumab for advanced gastric cancer
Region
| Japan |
Condition
Condition
untreated advanced gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safty and efficacy of capecitabine plus cisplatin (plus trastuzumab)
for previously untreated advanced gastric cancer.
Basic objectives2
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
The safty and efficacy of the biomarker; TP/DPD, HR, ER, PgR status
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
A group(HER2 negative):XP(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 q3w)
B group(HER2 positive):XP+HER(CDDP 80mg/m2 d1 and Capecitabine 2000 mg/m2 d1-15 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) Written informed conscent to recieve this chemotherapy
(3) More than 20 years old
(4) Eastern Cooperative Oncology Groupe (ECOG) performance status of 0-2
(5) Life expectancy mor than 12 weeks
(6) Presence of a measureable lesion for evaluation according to RECIST 1.1
(7) Adequate organ function as follows:
1. WBC count 4,000-12,000/mm3
2. Platelet count more than 100,000/mm3
3. Hemoglobin more than 8.0 g/dl
4. Serum bilirubin level less than 1.5 mg/dl
5.Ast and ALT less than 100IU/l
6. Alp within twice the normal upper limits
7. Serum creatinin level less than 1.5mf/dl
(8) The patients can take food oraly
(9) Without previous medication history such as radiation therapy, chemotherapy and immunotherapy (except adjuvant chenmotherapy)
(10) Electrocardiogram was performed within 28 days
Key exclusion criteria
(1) Forbidden case to use capecitabine and/or cisplatin
(2) Infection or inflammatory case
(3) Severe heart disease
(4) Severe complicated case such as ileus, interstitial pneumonia, uncontrolled DM, liver cirrhosis etc
(5) a lot of ascites
(6) many bone metastasis
(7) brain metastasis
(8) repeated gastrointestinal bleeding
(9) severe psychological disease
(10) complicated other active cancer
(11) pregnant or intended to be pregnant
(12) intend to make pregnant
(13) others
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro |
Organization
Kawasaki Medical University
Division name
Digestive surgery
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideo Matsumoto |
Organization
Kawasaki Medical University
Division name
Digestive surgery
Zip code
Address
577 Matsushima, Kurashiki, Okayama
TEL
086-462-1111
Homepage URL
h-matsu@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Digestive surgery, Kawasaki Medical University
Institute
Department
Personal name
Funding Source
Organization
non
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
川崎医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Primary endpoint: PFS
Secondary endpoints: Overall responce rate, Disease control rate, Overall survival, biomarker( TP/DPD, ER, PGR, HER2)
Management information
Registered date
| 2011 | Year | 07 | Month | 19 | Day |
Last modified on
| 2017 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007036
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
