Malignant pleural mesothelioma
Conditions
Interventions
Induction chemotherapy consists of 3 courses, and one course lasts 21 days. 500mg/m2 of pemetrexed and 60mg/m2 of cisplatin are administered intravenously on the day 1 of each course. After inducti
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proved malignant pleural mesothelioma 2) Completely resectable disease 3) T0-3, N0-2, M0 4) Measurable disease not mandatory 5) No prior therapy for mesothelioma 6) Age : 20 - 75 years 7) Performance status of 0-1 (ECOG) 8) Predicted forced expiratory volume at 1 second after extrapleural pneumonectomy: 1L or greater 9) Adequate major organ function 10) Patients with an estimated life expectancy of more than 12 weeks 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Serious or uncontrolled complication 2) Uncontrolled hypertension or diabetes mellitus 3)Active systemic infection 4) Active concomitant malignancy 5)With prior unapproved drugs or investigational new drugs 6) With a history of sensitivity to platinum agent, folic acid or vitamin B12 7) Women with confirmed, lactating or suspected pregnancy. Patients who won't avoid pregnancy. 8) Peripheral neuropathy (grade 2 or greater) 9) Interstitial pneumonia or pulmonary fibrosis on chest-X ray 10) Medically endorsed anticonception can't be assured till 90 days after the final administration 11) Inappropriate patients for entry on this trial in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MCR rate by P/D or extrapleural pneumonectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| -P/D rate -MCR rate by P/D - Overall survival time -Pulmonary function at three months after surgery -Adverse event rate -Treatment related mortality -Response rate of induction chemotherapy | — |
Countries
Japan
Contacts
Public ContactSeiki Hasegawa
Hyogo College of Medicine Department of Thoracic Surgery
Outcome results
None listed