Thymic carcinoma
Conditions
Interventions
administration of nedaplatin and gemcitabine
Sponsors
First Department of Internal Medicine, Shinshu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Historogically or cytologically confirmed thymic carcinoma. 2)Unresectable disease or recurrent disease after surgery. 3)One or more prior chemotherapy or chemoradiotherapy. 4)Measurable by RECIST criteria. 5)ECOG Performance status of 0-2. 6)Sufficient organ functions. 1.WBC >= 4000/mm3 2.neutrophil >= 2000/mm3 3.Hb >= 9.0g/dL 4.Plt >= 100000/mm3 5.T-bil < 1.5mg/dL 6.AST, ALT < 100IU/L 7.Cr < 1.5mg/dL 8.PaO2 >= 60Torr or SpO2 >= 90% 7)Expected to live over 3 months 8)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Symptomatic brain metastasis 2)Poorly controlled pleural or pericardial effusion. 3)Need for thoracic radiation. 4)History of double cancer within 5 years. 5)Serious complications. 1.Uncontrollable heart disease (heart failure, ischemic heart disease). 2.History of myocardial infarction within 6 months. 3.Interstitial pneumonia or pulmonary fibrosis detectable on chest X ray. 4.Uncontrollable diabetes mellitus. 5.Uncontrollable hypertension. 6.Active infection. 6)History of severe allergy. 7)Previous administration of nedaplatin or gemcitabine. 8)Now pregnant or lactation. 9)Judged to be not suitable by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, adverse events | — |
Countries
Japan
Contacts
Public ContactShintaro Kanda
Shinshu University School of Medicine First Department of Internal Medicine
Outcome results
None listed