UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006755
Receipt No. R000007930
Scientific Title A dandomized phase ll study consisting S-1 + CDDP (SP) and Capecitabin + CDDP (XP) for adversed/metastatic gastric cancer with mesurable lesions and HER2 negative tumor (HERBIS-4A) (OGSG 1105)
Date of disclosure of the study information 2011/11/21
Last modified on 2020/01/22

* 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 dandomized phase ll study consisting S-1 + CDDP (SP) and Capecitabin + CDDP (XP) for adversed/metastatic gastric cancer with mesurable lesions and HER2 negative tumor (HERBIS-4A) (OGSG 1105)
Acronym HER2 Based Strategy in Stomac Cancer
(HERBIS-4A) (OGSG 1105)
Scientific Title A dandomized phase ll study consisting S-1 + CDDP (SP) and Capecitabin + CDDP (XP) for adversed/metastatic gastric cancer with mesurable lesions and HER2 negative tumor (HERBIS-4A) (OGSG 1105)
Scientific Title:Acronym HER2 Based Strategy in Stomac Cancer
(HERBIS-4A) (OGSG 1105)
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A randomized phase ll study consisting S-1 + CDDP and Capecitabin + CDDP for advanced/metastatic gastric cancer with mesurable lesions and HER2 negative tumor (HERBIS-4A) is carried out to know the effectiveness and feasibility by comparing the two groups.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate (RR)
Key secondary outcomes Progression-free survival(PFS)
Overall survival (OS)
Time to treatment failure (TTF)
Incidence of adverse evnts

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 S-1+CDDP (SP)
Day1 to 21:S-1 take orally(twicw a day)
Day8:CDDP 60mg/m2 Drip infusion
Day22 to 35:14 days rest
Interventions/Control_2 S-1+CDDP
Day1 to 14:Capecitabin take orally(twicw a day)
Day1 CDDP:Drip infusion
Day15 to 21:7 days rest
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1)proven gastric adenocarcinoma R0 unresectable and HER2 negative histologically, or reccurent gastric cancer not undergo postoperative adjuvant chemotherapy
2)with mesurable lesions
3)patients between 20 and 75 years old
4)PS(ECOG) between 0 and 2
5)patients who not undergo chemotherapy and/or radiation therapy
6)with a good condition of important organs recent 14 days
a)WBC:>=3,000/mm3
b)neutrophil>=1,500/mm3
c)platelet>=100,000/mm3
d)hemoglobin>=8.0g/dl
e)total bilirubin<=1.5mg/dl
f)AST(GOT)<=100IU/L (with hepatic metastasis <=150)
g)ALT(GPT)<=100IU/L (with hepatic metastasis <=150)
h)serum creatinine<=1.2mg/dl
i)creatinin clearance>=60ml/min
7)expected survival longer than 3 months
8)patients who can take orally
9)written informed consent to participate in this study
Key exclusion criteria 1)with prior chemotherapy and/or radiation therapy
2)with active double cancer(*)
*simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years.
Carcinoma in situ or Cancers localized in membranous layer are not included to double cancer.
3)with symptoms of brain metastasis
4)with history of severe allergy against medicines
5)with following diseases
a)uncontrolled DM
b)uncontrolled high-blood pressure
c)liver cirrhosis and/or liver failure
d)renal failure
e)interstitial pneumonitis, pulmonary fibrosis, severe athelectasis
f)active infection diseases
g)heart failure, cardic infarction and/or severe disorder on ECG during recent 6 months
6)HBs positive status
7)with severe diarrhea (watery stool over 4 times a day)
8)patients who have flucytosine, fenitoin or walfarin
9)patients who have steroids continuously
10)women pregnant or women who like to be pregnant or males who like to have their own baby
11)patients decided not to register to this study due to psychologic diseases and/or psychological symptoms
12)patients whom doctor decide not ro register to this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisahito Kawakami
Organization Kinki University, Faculty of Medicine
Division name Departmenr of Medical Oncology
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, 589-8511 Japan
TEL 072-366-0221
Email kawakami_h@dotd.med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Furukawa
Organization Kinki University School of Medicine
Division name Department of surgery
Zip code
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan
TEL 072-366-0221
Homepage URL
Email hiroshi.furukawa@tokushukai.jp

Sponsor
Institute Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization Osaka Clinical Study Supporting Organization
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 関西労災病院(兵庫県)、堺市立総合医療センター(大阪府)、東大阪市立病院(大阪府)、箕面市立病院(大阪府)、八尾市立病院(大阪府)、市立貝塚病院(大阪府)、大阪府立成人病センター(大阪府)、近畿大学医学部(大阪府)、近畿中央病院(兵庫県)、北野病院(大阪府)、星ヶ丘厚生年金病院(大阪府)、松下記念病院(大阪府)、大阪医療センター(大阪府)、西宮市立中央病院(兵庫県)、関西医科大学附属香里病院(大阪府)、兵庫県立西宮病院(兵庫県)、兵庫医科大学(兵庫県)、京都逓信病院(京都府)、大阪大学(大阪府)、大阪労災病院(大阪府)、市立豊中病院(大阪府)、大阪市立総合医療センター(大阪府)、近畿大学附属奈良病院(奈良県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 21 Day

Related information
URL releasing protocol https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292554/
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292554/
Number of participants that the trial has enrolled 84
Results
Response rate did not differ significantly between the capecitabine-cisplatin and S-1-cisplatin groups. S-1-cisplatin tended to confer a better progression-free survival, overall survival, and time to treatment failure compared with capecitabine-cisplatin. Common hematologic toxicities occurred in both groups. Anorexia, fatigue, and hyponatremia occurred more frequently in the capecitabine-cisplatin group.
Results date posted
2020 Year 01 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 10 Month 23 Day
Baseline Characteristics
Japanese patients with HER2 negative advanced gastric cancer with measurable lesions.
Participant flow
Eligible patients were randomly assigned to receive either capecitabine at 1,000 mg/m2 twice daily for 14 days plus cisplatin at 80 mg/m2 on day 1 every 3 weeks (n = 43) or S-1 at 40-60 mg twice daily for 21 days plus cisplatin at 60 mg/m2 on day 8 every 5 weeks (n = 41). 
Adverse events
Common hematologic toxicities of grade 3 or 4 included anemia and neutropenia in both groups. However, anorexia, fatigue, and hyponatremia of grade 3 or 4 occurred more frequently in the capecitabine-cisplatin group.
Outcome measures
The primary endpoint of the study was response rate.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 10 Month 31 Day
Date of IRB
2011 Year 10 Month 21 Day
Anticipated trial start date
2011 Year 12 Month 20 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 11 Month 27 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 21 Day
Last modified on
2020 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.