A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma
Not Applicable
- Conditions
- Malignant pleural mesothelioma
- Registration Number
- JPRN-UMIN000001154
- Lead Sponsor
- Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1. Serious or uncontrolled complication 2. Active infection 3. Active concomitant malignancy 4. Symptomatic brain metastasis 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 9. Interstitial pneumonia or fibroid lung 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete resection rate with extrapleural pneumonectomy Mortality rate
- Secondary Outcome Measures
Name Time Method Completion rate of trimodality therapy Disease-free survival (at 2 years) Overall survival (at 2 years) Response rate of induction chemotherapy Morbidity rate