UMIN-CTR Clinical Trial

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 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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007930