UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006105 |
|---|---|
| Receipt number | R000007164 |
| Scientific Title | A randomized phase ll study comparing TS-1 + CDDP (SP) therapy and Capecitabine + CDDP (XP) therapy for patients with metastatic lesions after Surgery plus TS-1 therapy (HERBIS-2) (OGSG 1103) |
| Date of disclosure of the study information | 2011/08/08 |
| Last modified on | 2022/09/25 21:17:55 |
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Basic information
Public title
A randomized phase ll study comparing TS-1 + CDDP (SP) therapy and Capecitabine + CDDP (XP) therapy for patients with metastatic lesions after Surgery plus TS-1 therapy (HERBIS-2) (OGSG 1103)
Acronym
HER2 based astrategy in astomach Cancer(HERBIS-2) (OGSG 1103)
Scientific Title
A randomized phase ll study comparing TS-1 + CDDP (SP) therapy and Capecitabine + CDDP (XP) therapy for patients with metastatic lesions after Surgery plus TS-1 therapy (HERBIS-2) (OGSG 1103)
Scientific Title:Acronym
HER2 based astrategy in astomach Cancer(HERBIS-2) (OGSG 1103)
Region
| Japan |
Condition
Condition
recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the two regimens ; (A) TS-1 + CDDP (SP), and (B) capecitabine + CDDP (XP), in terms of the effectiveness and feasibility for patients with metastatic lesions after surgery plus TS-1 therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival : OS
Key secondary outcomes
Responce rate (RR)
Prgression-free survival : PFS
Time to treatment failure : TTF
Incidence of adverse 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
Group A
TS-1 + CDDP (SP)
3 weeks followd by 2 weeks rest
Interventions/Control_2
Group B
Capecitabine + CDDP (XP)
2 weeks followd by 1 week 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with metastatic lesions after R0 surgery plus TS-1 therapy recommended based on guide line 3rd edition.
1) HER2(-) or unknown adenocarcinoma on stomach
2) with diagnosis of metastatic lesions after more than 8 weeks of TS-1 administration and more than 6 months rast
3) patients 20 years of age and older
4) PS (ECOG) between 0 and 2
5) without prior chemotherapy and/or radiation therapy
6) with a dood condition of important organs within 14 days of registration
1.WBC >= 3,000/mm3
2.neutrophil >= 1,500/mm3
3.platelet >= 100,000/mm3
4.hemoglobin >= 8.0g/dL
5.AST/ALT <= 100IU/L , <=150 IU/L for patients with liver metastasis
6.total bilirubin <= 1.5mg/dL
7.serum creatinine <= 1.2mg/dL
8.creatinine clearance >=60mL/min , CC by Cockcroft-Gault method is available
7) expected survival longer than 3 months
8) patients who can eat orally
9) written informed consent to participate in this study
Key exclusion criteria
1) patients administrated fluoropyrimidine before less than 6 months of the registration
2) with a history of over 120mg/m2 dose platinum administrarion
3) with radiation therapy after recurrence
4) with active double cancers whose disease free period is shorter than 5 years
5) with brain metastasis and symptoms on brain
6) with a histoyr of severe allergy against medicines
7) with other disease
1.uncontrolled DM
2.uncontrolled hypertension
3.liver cirrhosis or liver dysfunction
4.renal failure
5.interstitial pneumonitis, pulmonary fibrosis or severe emphysema
6.active infection disease
7.cardiac failure, cardiac infarction, angina pectoris, and/or remarkable ECG change
8) with HBs (+)
9) severe diarrhea (more than 4 times/ day or watery stool)
10) patients whom administrated Flucitosine, Fenitoin and/or Warfarin
11) women who are pregnant or expect to be pregnant, or males who expect to have children
12) patients whom doctor in chief deciders not to register to this study due to psychological disease or symptom
13) patients whom doctor in chief deciders not to register to this study due to the other reasons
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Fujitani |
Organization
Osala General Medical Center
Division name
Departmenr of Surgery
Zip code
Address
3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka-City
TEL
06-6692-1201
fujitani@gh.opho.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
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
大阪府立急性期総合医療センター（大阪府）、八尾市立病院（大阪府）、関西労災病院（兵庫県）、大阪厚生年金病院（大阪府）、市立堺病院（大阪府）、大阪医科大学（大阪府）、東大阪市立総合病院（大阪府）、京都逓信病院（京都府）、ベルランド総合病院（大阪府）、西宮市立中央病院（兵庫県）、星ヶ丘厚生年金病院（大阪府）、大阪大学（大阪府）、兵庫医科大学（兵庫県）、大阪医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-020-01711-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-020-01711-z
Number of participants that the trial has enrolled
20
Results
We performed a pooled analysis of HERBIS-4A and HERBIS-2.
SP showed a longer progression-free survival(6.4 versus 5.1 months; hazard ratio(HR),0.666), overall survival(14.8 versus 10.6 months; HR,0.695),and time to treatment failure(4.6 versus 3.6 months;HR,0.668) as well as a higher disease control rate(86.4% versus 68.1%, P=0.149) compared with XP.
Results date posted
| 2021 | Year | 08 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 03 | Day |
Baseline Characteristics
chemotherapy-naive patients with HER2-negative advanced gastric cancer(HERBIS4-A)
HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of above 6 months(HERBIS-2)
Participant flow
Patients were randomly assigned to receive either SP [S-1 (10-60mg twice daily for 21 days) plus cisplatin (60mg/m2 on day 8), every 5 weeks] or XP [capecitabine (1000mg/m2 twice daily for 14 days) plus cisplatin (80mg/m2 on day 1), every 3 weeks].
Adverse events
.
Outcome measures
overall survival (14.8 versus 10.6 months; HR, 0.695; P=0.099)
progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P=0.062]
time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P=0.045)
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 | 07 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 02 | 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=R000007164
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