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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006668
Receipt No. 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

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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
Email 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
Email kscc2@cres-kyushu.or.jp

Sponsor
Institute Kyushu Study group of Clinical Cancer
Institute
Department

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
Email

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
URL(English) https://upload.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


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