UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006179 |
|---|---|
| Receipt number | R000007275 |
| Scientific Title | A randomized phse ll study consistiong S-1+DTX and S-1+CDDP for advanced/metastatic gastric cancer without any mesurable lesions (HERBIS-3) (OGSG 1104) |
| Date of disclosure of the study information | 2011/08/20 |
| Last modified on | 2022/09/25 19:57:45 |
* 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 randomized phse ll study consistiong S-1+DTX and S-1+CDDP for advanced/metastatic gastric cancer without any mesurable lesions (HERBIS-3) (OGSG 1104)
Acronym
A randomized phse ll study consistiong S-1+DTX and S-1+CDDP for advanced/metastatic gastric cancer without any mesurable lesions (HERBIS-3) (OGSG 1104)
Scientific Title
A randomized phse ll study consistiong S-1+DTX and S-1+CDDP for advanced/metastatic gastric cancer without any mesurable lesions (HERBIS-3) (OGSG 1104)
Scientific Title:Acronym
A randomized phse ll study consistiong S-1+DTX and S-1+CDDP for advanced/metastatic gastric cancer without any mesurable lesions (HERBIS-3) (OGSG 1104)
Region
| Japan |
Condition
Condition
advanced/metastatic gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized phase ll study consisting S-1+DTX and S-1+CDDP for advanced/metastatic gastric cancer without any measurable lesions (HERBIS-3) is performed to know the effectiveness and the feasibility by comparing the two groups.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival : OS
Key secondary outcomes
Progression-free survival : PFS
Incidence of Advers Events
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
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug : S-1+DTX
S-1 : 80mg/m2/day po on Days 1-14, 7 days rest
DTX : 40mg/m2 div on Day 1
Interventions/Control_2
Drug : S-1+CDDP
S-1 : 80mg/m2/day po on Days 1-21, 14days rest
CDDP : 60mg/m2/day div on Day 8
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 cancer histologically
2)patients with gastric cancer who cannnot undergo D0 resection or patients who have undergone R1/2 resection, or patients with metastatic gastric cancer without any prior chemotherapy
3)without any mesurable lesions by RECIST(ver 1.1)(*)
*non lymph node tumors more than 10mm in long diameter by under 5mm slice CT or over 2 times of slice width by more wider slice CT
*more than 15mm in short diameter by under 5mm slice CT
4)patients who can eat orally without severe peritoneal metastases(*)
*ascites both in upper abdomen and lower abdomen by CT
*patients who received extraction of ascites to reduce symptoms less than 14 days before registration
*complete ileus clinically
5)HER2(-) or unknown HER2
6)without active bleeding from original tumor
7)without brain metastases
8)without any prior chemotherapy and/or radiationtherapy
9)patients between 20 and 75 years old
10)PS(ECOG) between 0 and 2
11)with a good condition of important organs
1.WBC : >= 3,000/mm3 and <= 12,000/mm3
2.neutrophil >= 2,000/mm3
3.platelet >= 100,000/mm3
4.hemoglobin >= 9.0g/dL
5.ALT/AST <= 100IU/L
6.total bilirubin <= 1.5mg/dL
7.serum creatinine <= 1.2mg/dL
8.Creatinine clearance >= 60mL/min
12)expected survival longer than 3 months
13)written informed consent to participate in this study
Key exclusion criteria
1)with active double cancer (*)
*Simultaneous double cancer or sequential double cancer whose rest is shorter than 5 years.
Carcinoma in situ or cancers localized in membranous layer are not included to double cancer.
2)with positive HBs
3)with uncontrolled heart diseases (congention heart failure) or unstable angina pectoris, or with a history of cardiac infarction within 6 months
4)with uncontrolled DM or hypertension
5)with interestitial pneumonitis or pulmonary fibrosis
6)women pregnant and/or nursing or women who like to be pregnant or males who like to have their own baby
7)with other diseases which disturb the course of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukinori Kurokawa |
Organization
Osaka University
Division name
Department of Gastroemtetological Surgery
Zip code
Address
2-2-2,Yamadaoka, Suita City, Osaka, Japan 565-0871
TEL
06-6879-3251
ykurokawa@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirosh 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
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
八尾市立病院（大阪府）、堺市立総合医療センター（大阪府）、大阪医療センター（大阪府）、関西労災病院（兵庫県）、箕面市立病院（大阪府）、大阪府立急性期総合医療センター（大阪府）、大阪医科大学（大阪府）、西宮市立中央病院（兵庫県）、大阪大学消化器外科（大阪府）、市立吹田市民病院（大阪府）、兵庫県立西宮病院（兵庫県）、市立貝塚病院（大阪府）、大阪警察病院（大阪府）、JCHO大阪病院（大阪府）、大阪労災病院（大阪府）、北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs10120-020-01112-1
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10120-020-01112-1
Number of participants that the trial has enrolled
61
Results
The 2-year OS rates were 43.3% with DS and 43.3% with DS and 30.0% with CS (log-rank P=0.113), with a hazard ratio of 0.617 (95% confidence interval 0.337-1.128), indicating non-inferiority of DS ti CS with respect to OS (P<0.001).
Results date posted
| 2022 | Year | 09 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
Eligible patients had unresectable or recurrent HER2-negative AGC without measurable lesions.
Participant flow
Sixty-one patients were randomly assigned to DS (docetaxel 40mg/m2 on day 1, S-1 80-120mg on days 1-14, every 3 weeks) (n=30) or CS(cisplatin 60mg/m2 on day 8, S-1 80-120mg on days 1-21, every 5 weeks) (n=31). One CS patient was ineligible due to HER2 positivity.
Adverse events
The most common grade 3-4 mon-hematological toxicity was fatigue (7% with DS, 13% with CS), followed by anorexia (3% with DS, 10% with CS) and diarrhea (3% with DS, 10% with CS).
Outcome measures
The 2-year OS rates were 43.3% with DS and 43.3% with DS and 30.0% with CS (log-rank P=0.113), with a hazard ratio of 0.617 (95% confidence interval 0.337-1.128), indicating non-inferiority of DS ti CS with respect to OS (P<0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 09 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 16 | 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=R000007275
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
