UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013669 |
|---|---|
| Receipt number | R000015951 |
| Scientific Title | A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer |
| Date of disclosure of the study information | 2014/04/08 |
| Last modified on | 2014/04/08 15:28:59 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer
Acronym
SGCSG G-04
Scientific Title
A PhaseII study of XP(capecitabine plus cisplatin) combination therapy for HER2 negative advanced/recurrent gastric cancer
Scientific Title:Acronym
SGCSG G-04
Region
| Japan |
Condition
Condition
HER2 negative advanced/recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety assessment of XP therapy for HER2 negative advenced and recurrent gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Time to response, Disease control rate, Progression free survival, Time to treatment failure, Overall survival, Relative dose intensity, 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
CDDP80mg/m2, Day1
Capecitabine2000mg/m2, Day1-15
Tri-weekly, until PD
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)Negatibe HER2 status if tested.
(3)Written informed consent 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 measureable and non-measureable according to RECIST(Response Evaluation Criteria in Solid Tumors) guideline.
(8)Adequate organ function as follows:
1.Nuetrophils count more than 1,500/mm3
2.Platelet count more than 100,000/m3
3.Serum bilirubin level than 1,5mg/dl
4.AST and ALT less than 100IU/l
5.Serum creatinine level less than 1.2mg/dl
6.Cretinine clearance more than 50mL/min
(9)Without previous chemotherapy(except adjuvant chemotherapy).
Key exclusion criteria
(1)Forbidden case to use capecitabine and cisplatin.
(2)R1 operation(histologically positive PM, OM, LM, VM).
(3)Infection or inflammatory case.
(4)Severe heart disease.
(5)Severe complicated case such as ileus, intestitial pneumonia, uncontrolled DM, liver cirrhosis etc.
(6)Difficulty to join the trial due to psychosis nervous system damage.
(7)Complicated other active cancer.
(8)patient who want to be pregnant and/or pregnant woman.
(9)Intend to make pregnant.
(10)Active hepatitis type HB positive(HBs antigen, HBc antibody and HBs antibody).
(11)Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study).
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hirahara |
Organization
Shimane university faculty of medicine
Division name
Department of digestive and general surgery
Zip code
Address
89-1 Enya-cho, Izumo city, Shimane prefecture, 693-8501, Japan
TEL
0853-20-2232
norinori@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hirahara |
Organization
Shimane university faculty of medicine
Division name
Department of digestive and general surgery
Zip code
Address
89-1 Enya-cho, Izumo city, Shimane prefecture, 693-8501, Japan
TEL
0853-20-2232
Homepage URL
norinori@med.shimane-u.ac.jp
Sponsor or person
Institute
SGCSG:Shimane Gstroenterological Vancer Study Group
Institute
Department
Personal name
Funding Source
Organization
SGCSG:Shimane Gstroenterological Vancer Study Group
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 08 | 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
| 2014 | Year | 04 | Month | 08 | Day |
Last modified on
| 2014 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015951
