UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028329 |
|---|---|
| Receipt number | R000032420 |
| Scientific Title | Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy. |
| Date of disclosure of the study information | 2017/09/13 |
| Last modified on | 2020/08/24 08:43:15 |
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Basic information
Public title
Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.
Acronym
TAS114_GC study
Scientific Title
Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.
Scientific Title:Acronym
TAS114_GC study
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety os TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Objective Response Rate : ORR
Key secondary outcomes
Disease control rate: DCR
Progression free survival: PFS
Overall survival: OS
Adverse Events: AE
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
1 cycle is 21days.
TAS-114(400mg) and S-1(30mg/m2) are administered orally twice daily for 14 days followed by 7days rest.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
2)Inoperable, recurrent or metastatic disease.
3)Tumor progression during prior chemotherapy or within 2 months after prior chemotherapy
4)>=20 years old
5) ECOG performance status 0 or 1
6)Measurable disease according to RECIST ver1.1
7)Prior chemotherapies for advanced gastric cancer are as follows. (In case of progression during adjuvant/neoadjuvant therapy or <=6 months after the last administration of adjuvant/ neoadjuvant therapy, the adjuvant/neoadjuvant therapy will be considered as one prior treatment.)
i. Include chemotherapy with 5-FU
ii. Include chemotherapy with platinum derivative
iii. Include chemotherapy with taxane or irinotecan
iv. No. of prior chemotherapies>=2.
8)Adequate organ function
9)No blood transfusion within 7 days prior to enrollment
10)AE related to prior chemotherapy, radiation therapy or surgery must be Grade <=1 according to CTCAE (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia)
11)Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment
12)Adequate oral intake
13)Written informed consent
Key exclusion criteria
1)Administration of chemotherapy within 2 weeks prior to enrollment
2)Major surgery or radiation therapy within 4 weeks prior to enrollment. Except bowel bypass surgery or enterostomy has passed over 2 weeks.
3)Investigational drugs was administrated within 4 weeks prior to enrollment
4)Prior chemotherapy with TAS-114.
5)Known hypersensitivity to S-1 or excipients.
6)Patients with CNS metastases.
7)Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma.
8)Any severe and/or uncontrolled medical conditions.
9)Active hepatitis
10)Chronic treatment with steroids or another immunosuppressive agent.
11)Patient is unwilling to practice appropriate contraception during the study and the contraception period after the discontinuation of the protocol treatment
12)Patient is unwilling or unable to comply with the protocol
13)Patient is judged by the investigator to be inappropriate for study participation for any reason.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Shitara |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
04-7133-1111
TAS114_GC_core@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Akihito |
| Middle name | |
| Last name | Kawazoe |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
TEL
04-7133-1111
Homepage URL
TAS114_GC_core@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NCC IRB
Address
6-5-1,Kashiwanoha,Kashiwa,Chiba,277-8577,Japan
Tel
04-7133-1111
irboffice@east.ncc.go.jp
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
国立研究開発法人 国立がん研究センター東病院(千葉県）
がん研有明病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
Not Release
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10120-020-01107-y
Number of participants that the trial has enrolled
20
Results
ORR 5%, DCR 70%
Results date posted
| 2020 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gastric cancer
Participant flow
informed consent
Adverse events
anemia, leucopenia, neutropenia, etc.
Outcome measures
ORR, DCR, PFS, OS, etc
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 21 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032420
