UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006864 |
|---|---|
| Receipt number | R000007989 |
| Scientific Title | A randomized phase l study on TS-1+CDDP+CPT-11(IPS) therapy for patients with advanced/metastatic gastric cancer(HERBIS-4A) (OGSG 1106) |
| Date of disclosure of the study information | 2011/12/10 |
| Last modified on | 2023/09/24 13:36:02 |
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Basic information
Public title
A randomized phase l study on TS-1+CDDP+CPT-11(IPS) therapy for patients with advanced/metastatic gastric cancer(HERBIS-4A) (OGSG 1106)
Acronym
OGSG 1106
HER2 Based Strategy in Stomach Cancer(HERBIS-4B) (OGSG 1106)
Scientific Title
A randomized phase l study on TS-1+CDDP+CPT-11(IPS) therapy for patients with advanced/metastatic gastric cancer(HERBIS-4A) (OGSG 1106)
Scientific Title:Acronym
OGSG 1106
HER2 Based Strategy in Stomach Cancer(HERBIS-4B) (OGSG 1106)
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To know the effectiveness and feasibility of a regimen consisted of TS-1+CDDP+CPT-11 (IPS) for unresectable advanced gastric cancer.
To know the feasibility and recommended dose of IPS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
maximum tolerated dose and recommended dose
Key secondary outcomes
Response Rate (RR)
Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TS-1:dosage 80mg/m2, take orally 3weeks, and 2 weeks rest
CDDP:60mg/m2, the intravenous drip infusion on the 8 days
CPT-11:the intravenous drip infusion on the 8 and 22 days
One course lasts 5 weeks (35 days) , repeat for a maximam of 6 courses.
Interventions/Control_2
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)gastric cancer proven histologically
Cancers located within 2-3cm of E-G junction are eligible.
2)Unresectable advanced gastric cancer (Stage IV)
Cancers with metastatic lymph nodes of para-aortic a2 or b1 station are excluded.
3)with measurable lesions by RECIST version 1.1
4)HER2(-) or unknown HER2
5)patients between 20 and 75 years old at registration
6)PS (ECOG) between 0 and 1
7)without prior chemotherapy and/or radiation therapy
8)without any ascites and/or thoracic fluid to be removed
9)without any brain metastasis
10)with a good condition of important organs within 14 days of registration
a)WBC >= 3,500/mm3
b)neutrophil >= 2,000/mm3
c)platelet >= 100,000/mm3
d)AST/ALT < 100 IU/L
< 200 IU/L for patients with liver metastasis
e)total bilirubin < 1.5mg/dL
f)serum creatinine <= 1.2mg/dL
g)Creatinin clearance >= 60ml/min
CC by Cockcroft-Gault method is available
11)patients who can eat orally
12)expected survival longer than 3 months
13)written informed consent to participate in this study
Key exclusion criteria
1)with active double cancers whose disease free period is shorter than 5 years
Carcinoma in situ can be included
2)with a history of severe allergy against medicines
3)with severe diarrhea (more than 4 times/day) or watery stool
4)with body temperature over 38 degrees Celsius and/or infectious disease which needs therapy
5)with severe myelo-dysfunction, renal dysfunction and/or liver dysfunction
6)with other sever diseases
a)interstitial pneumonitis, pulmonary fibrosis or severe emphysema
b)cardiac failure, cardiac infarction, angina pectoris
c)renal dysfunction
d)liver dysfunction
e)intestinal paralysis, ileus
f)jaundice
g)uncontrolled DM
7)with HBs (+)
8)patients whom administered Flucitosine or Athazanavil sulfate
9)patients whom administered Fenitoin and/or Warfarin
10)general administration of steroids
11)women who are pregnant or expect to be pregnant, or nursing female
12)patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms
13)patients whom doctor in chief decides not to register to this study due to other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Goto |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Center
Zip code
Address
2-7, Daigakucho, Takatsuki, Osaka, 569-8686 Japan
TEL
072-683-1221
in2030@poh.osaka-med.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 Gastroestinal 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
大阪医科大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-023-02376-0
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-023-02376-0
Number of participants that the trial has enrolled
12
Results
With reference to the number of grade 4 or higher adverse event occurrences, the recommended doses were determined to be irinotecan 100 mg/m2, cisplatin 60 mg/m2, and S-1 80 mg/m2; the maximum tolerated doses were irinotecan 125 mg/m2, cisplatin 60 mg/m2, and S-1 80 mg/m2.
Results date posted
| 2023 | Year | 09 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 07 | Month | 07 | Day |
Baseline Characteristics
chemotherapy-naive patients with HER2-negative advanced gastric cancer
Participant flow
Twelve patients were enrolled in two dose-level cohorts.
Adverse events
In the level 1 cohort (irinotecan 100 mg/m2, cisplatin 60 mg/m2, and S-1 80 mg/m2), dose-limiting toxicity including grade 4 neutropenia and febrile neutropenia occurred in one of six patients, whereas in the level 2 cohort (irinotecan 125 mg/m2, cisplatin 60 mg/m2, and S-1 80 mg/m2), dose-limiting toxicities including grade 4 neutropenia developed in two of six patients. Common grade 3 or higher adverse events were neutropenia (75%; n = 9), anemia (25%; n = 3), anorexia (8%; n = 1), and febrile neutropenia (17%; n = 2).
Outcome measures
The aim of this phase I dose-escalation study was to determine the maximum tolerated dose and recommended dose of the combination of irinotecan, cisplatin, and S-1 in chemotherapy-naive patients with HER2-negative advanced gastric cancer.
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
| 2012 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 01 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007989
