Thymoma/Thymic carcinoma
Conditions
Interventions
S-1 treatment S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 14, which is followed by 7 days rest. C
Sponsors
North Japan Lung Cancer Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven thymoma or thymic carcinoma 2. Unsuitable for curative radiotherapy or Unresectable 3. At least 1 prior chemotherapy 4. Progressive disease after the most recent chemotherapy regimen. 5. ECOG performance status 0-2 6. Age of 20 years or older 7. Presence of measurable lesions, as defined per RECIST 1.1 8. Adequate organ function 9. Life expectancy of at least 2 months 10. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Serious uncontrolled infections or body temperature higher than 38 degree centigrade 2. Continuous administration of an oral steroid or an immunosuppressive agent 3. With severe concurrent disease 4. Symptomatic brain metastasis 5. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 6. With severe drug allergies 7. Contraindication with S-1 8. Previous treatment with fluoropyrimidines such as S-1, UFT 9. Current use of flucytosine 10. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 11. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 12. Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Countries
Japan
Contacts
Public ContactAkira Inoue
Tohoku University Hospital Department of Respiratory Medicine
Outcome results
None listed