thymic carcinoma
Conditions
Interventions
Cisplatin is administered intravenously on day 1 with basing on the BSA for every 4 week and Irinotecan on day 1, 8, 15 for every 4 week. Cycles of IP treatment will be repeated every 4 weeks upto 6
Sponsors
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patients who were definitively diagnosed with having thymic carcinoma 2. Unsuitable for curative-intent treatment and previously untreated with chemotherapy 3. Age of 18 years or older 4. ECOG performance status 0-1 5. presence of measurable lesion with RECIST 1.1 criteria 6. With the status of four weeks from previous treatment (surgery, radiotherapy) at the time of beginning of IP chemotherapy 7. Adequate organ function 8. Life expectancy of at least 12 weeks 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. With concurrent active cancer 2. Serious uncontrolled infections 3. With fever at more than 38 degree in Celicius 4. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 5. 6. 7. With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 6. With sever complication associated with operation 7. Under continuous steroid therapy 8. With uncontrolled diabetes melitus 9. With uncontrolled hypertension 10 Unstable angina or previous history of myocardial infarction within six months 11. With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, overall survival, toxicity, number of cycles | — |
Countries
Japan
Contacts
Public ContactYusuke Okuma
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Department of Thoracic Oncology and Respiratory Medicine
Outcome results
None listed