A dandomized phase ll study consisting S-1 + CDDP (SP) and Capecitabin + CDDP (XP) for adversed/metastatic gastric cancer with mesurable lesions and HER2 negative tumor (HERBIS-4A) (OGSG 1105)
- Conditions
- Gastric Cancer
- Registration Number
- JPRN-UMIN000006755
- Lead Sponsor
- Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
- Brief Summary
Response rate did not differ significantly between the capecitabine-cisplatin and S-1-cisplatin groups. S-1-cisplatin tended to confer a better progression-free survival, overall survival, and time to treatment failure compared with capecitabine-cisplatin. Common hematologic toxicities occurred in both groups. Anorexia, fatigue, and hyponatremia occurred more frequently in the capecitabine-cisplatin group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 84
Not provided
1)with prior chemotherapy and/or radiation therapy 2)with active double cancer(*) *simultaneous double cancer or sequential double cancer whose interstitial period is shorter than 5 years. Carcinoma in situ or Cancers localized in membranous layer are not included to double cancer. 3)with symptoms of brain metastasis 4)with history of severe allergy against medicines 5)with following diseases a)uncontrolled DM b)uncontrolled high-blood pressure c)liver cirrhosis and/or liver failure d)renal failure e)interstitial pneumonitis, pulmonary fibrosis, severe athelectasis f)active infection diseases g)heart failure, cardic infarction and/or severe disorder on ECG during recent 6 months 6)HBs positive status 7)with severe diarrhea (watery stool over 4 times a day) 8)patients who have flucytosine, fenitoin or walfarin 9)patients who have steroids continuously 10)women pregnant or women who like to be pregnant or males who like to have their own baby 11)patients decided not to register to this study due to psychologic diseases and/or psychological symptoms 12)patients whom doctor decide not ro register to this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate (RR)
- Secondary Outcome Measures
Name Time Method Progression-free survival(PFS) Overall survival (OS) Time to treatment failure (TTF) Incidence of adverse evnts