Searching research on senior citizen's gastric cancer on clinical effect and safety of TS-1
- Conditions
- senior citizen's gastric cancer
- Registration Number
- JPRN-C000000285
- Lead Sponsor
- The Tokyo cooperative Oncology Group
- Brief Summary
Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7-37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes. Conclusions: The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1.History of severe drug allergic reaction 2.Severe Bone marrow suppression,renal and liver function disturbance 3.Concomitant therapy with another anticancer drug or flucytocine 4.Marked pleural effusion or ascites 5.Symptomatic brain metastasis 6.Intestinal fresh hemorrhage 7.Active secondary cancer 8.Accompanied serious diseases 9.Severe Ischemic heart disease or Arrhythmia which requires treatment 10.Watery diarrhea 11.Decision as ineligible by principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method TTF, OS, Safety, Home treatment period, home treatment rate