gastric cancer
Conditions
Interventions
1 cycle is 21days. TAS-114(400mg) and S-1(30mg/m2) are administered orally twice daily for 14 days followed by 7days rest.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate : ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate: DCR Progression free survival: PFS Overall survival: OS Adverse Events: AE | — |
Countries
Japan
Contacts
Public ContactAkihito Kawazoe
National Cancer Center Hospital East Department of Gastrointestinal Oncology
Outcome results
None listed