UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006755 |
|---|---|
| Receipt number | 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 | 2022/09/25 21:27:24 |
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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
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
hiroshi.furukawa@tokushukai.jp
Sponsor or person
Institute
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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 | 08 | Month | 16 | 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
| 2022 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007930
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