Phase II trial of S-1 treatment as palliative-intent chemotherapy for previously treated advanced thymic carcinoma
- Conditions
- thymic carcinoma
- Registration Number
- JPRN-UMIN000010736
- Brief Summary
One patient showed complete response and seven patients showed partial responses, resulting in a 30.8% response rate (90% confidence interval [CI], 18.3-46.9) and an 80.8% disease control rate (90% CI, 65.4-90.3) in 25 pts. The median PFS was 4.3 months (95% CI, 2.3-10.3 months) and median OS was 27.4 months (95% CI, 16.6-34.3). Adverse events of greater than 3 included neutropenia (12%), skin rash (8%), elevated alanine aminotransferase, and fatigue (4%). No treatment related death was observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 26
Not provided
1. With severe drug allergies for tegafur 2. With severe myleosuppression, renal disturbance, or liver disturbance 3. Current use of flucytosine 4. With severe uncontrolled systemic complication 5. Serious uncontrolled infections 6. With concrrent other malignant tumro 7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 8. With continuous diarrhea 9. With bowel paralysis or obstruction 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11.Symptomatic or uncontrolled brain metastasis 12. The patients treated with unapproved drugs within 30 days 13. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 14. Unable to intake orally
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method