UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006668 |
|---|---|
| Receipt number | R000007875 |
| Scientific Title | A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer. |
| Date of disclosure of the study information | 2011/11/04 |
| Last modified on | 2017/01/13 13:58:02 |
* 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 phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer.
Acronym
A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer.(KSCC1104)
Scientific Title
A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer.
Scientific Title:Acronym
A phase II study of modified XP therapy as first line chemotherapy for HER2 negative patient with unresectable or recurrent gastric cancer.(KSCC1104)
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of modified XP therapy as first line chemotherapy for HER2 negative patients with unresectable or recurrent gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival
Time to treatment failure
Time to failure of strategy
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
modified XP therapy
capecitabine 2,000mg/m2/day p.o. (day1-14)
CDDP 60mg/m2 i.v. (day1)
to be repeated every 3 weeks
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.Written informed consent
2.Appropriate for the study at the physician's assessment
3. Histologically confirmed HER2 negative unresectable or recurrent gastric cancer.
4.No prior chemotherapy for the patients with unresectable or recurrent gastric cancer
5. be able to take oral drugs
6.Aged 20<= years.
7.Life expectancy at least 3 months.
8.At least one measurable lesion based on the RECIST criterion.(within 28 days before registration)
9.ECOG performance status of 0-1.
10.Required baseline laboratory parameters (within 14 days before registration):
1 WBC more than 3000 and WBC less than 12000/mm3
2 Neu more than 1,500/ mm3
3 Plt more than 100,000/ mm3
4 Hb more than 9.0g/dl
5 T-Bil less than 1.5mg/dl
6 AST and ALT <= 100IU/l
(200IU/I in case of liver metastasis)
7 Cre < 1.5mg/dl
8 CCr >= 50mL/min
9 HER2 negative
Key exclusion criteria
1.Previously received chemotherapy including a Platinum based regimen
2. Allergy against platinum containing drugs or component of fluoropyrimidine.
3. History of severe adverse event suspected to be caused by dihydropyrimidine dehydrogenase (DPD) deficiency.
4. Relapsed within 6 months after completion of or during adjuvant chemotherapy
5. Prior chemotherapy and radiotherapy followed by primary tumor resection
6. Simultaneous or metachronous double cancers within 5 year. (Carcinoma in situ or intramucosal carcinoma curable with local therapy is excluded for active double cancer.)
7. Active infection and inflammation.
8. Positive for hepatitis B or C virus
9. Heart disease that is serious or requires hospitalization, or history of such disease within past 1 year
10. Severe complications, such as intestinal paralysis, ileus, interstitial lung disease, lung fibrosis,uncontrolled diabetes mellitus, renal failure and hepatocirrhosis.
11. Chronic diarrhea.
12. Active gastrointestinal haemorrhage
13. Body cavity fluids requiring drainage or other treatment
14. Brain or meningeal metastasis.
15. Pregnant or lactating women, and women who are capable of pregnancy or intend to get pregnant
16. No birth-control
17. Treated with antipsychotic drugs, or with mental disorder requiring medication.
18.Not appropriate for the study at the physician's assessment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kakeji |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe-city, 650-0017, JAPAN
TEL
092-631-2920
kscc2@cres-kyushu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KSCC |
Organization
Clinical Research Support Center Kyushu
Division name
KSCC
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka, Japan, 812-8582
TEL
092-631-2920
Homepage URL
kscc2@cres-kyushu.or.jp
Sponsor or person
Institute
Kyushu Study group of Clinical Cancer
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
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
春回会 井上病院(長崎県)
健康保険人吉総合病院(熊本県）
宗像医師会病院（福岡県）
神戸市立医療センター 中央市民病院（兵庫県）
国立病院機構別府医療センター（大分県）
国立病院機構大分医療センター（大分県）
佐世保市立総合病院（長崎県）
済生会福岡総合病院（福岡県）
社会保険田川病院（福岡県）
鹿児島共済会南風病院（鹿児島県）
健康保険八代総合病院（熊本県）
今給黎総合病院（鹿児島県）
熊本大学（熊本県）
長崎百合野病院（長崎県）
久留米大学（福岡県）
製鉄記念八幡病院（福岡県）
中津市立中津市民病院（大分県）
福岡市民病院（福岡県）
公立学校共済組合九州中央病院（福岡県）
松山赤十字病院（愛媛県）
九州大学（福岡県）
広島赤十字・原爆病院（広島県）
聖マリア病院（福岡県）
独立行政法人 労働者健康福祉機構 岡山労災病院（岡山県）
大分赤十字病院（大分県）
鹿児島大学（鹿児島県）
慈愛会 今村病院（鹿児島県）
済生会熊本病院（熊本県）
長崎大学（長崎県）
大分県立病院（大分県）
国立病院機構南九州病院（鹿児島県）
久留米大学医療センター（福岡県）
伊万里有田共立病院（佐賀県）
白十字会 佐世保中央病院 (長崎県）
済生会川内病院（鹿児島県）
九州大学病院別府病院（大分県）
三木市立三木市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27942930
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 | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | 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 | 11 | Month | 04 | Day |
Last modified on
| 2017 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
