malignant pleural mesothelioma
Conditions
Interventions
induction therapy: cisplatin plus pemetrexed maintenance therapy: pemetrexed
Sponsors
Kyoto Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven malignant pleural mesothelioma 2) No chemotherapy for mesothelioma 3) No indication for extrapleural pneumonectomy 4) Patients should be at least 20 years old and younger than 75 years old 5) ECOG performance status of 0 or 1 6) Functions of main organs are maintained, satisfying the following conditions Neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 AST and ALT <= 100IU/L Total bilirubin <= 1.5mg/dL Serum creatinine <= 1.2 mg/dL 7) With expected prognosis more than 3 months 8) With written informed consent
Exclusion criteria
Exclusion criteria: 1) With interstitial pneumonitis or pulmonary fibrosis which chest X-P can detect 2) With fluid accumulation which shoud be treated 3) With active double cancer 4) Patients who had already undergone cisplatin or pemetrexed 5) With poor-controled diabetes mellitus or hypertension 6) With liver cirrhosis diagnosed by imaging findings or clinical findings 7) History of severe heart disease (acute cardiac infarction or unstable angina within 6 months of registration, post-PTCA, post-CABG, sign of heart failure, uncontrollable arrythmia) 8) History of active infection 9) History of pregnancy or lactation 10) Sever drug allergy 11) No consent to blood transfusion 12) Evidence of bleeding tendency 13) No premedication of pemetrexed 14) Those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival from induction therapy | — |
Countries
Japan
Contacts
Public ContactAkihiro Nishiyama
Kurashiki Central Hospital Department of Respiratory Medicine
Outcome results
None listed