UMIN ID: UMIN000001154
Registered date:12/05/2008
A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Malignant pleural mesothelioma |
Date of first enrollment | 2008/05/01 |
Target sample size | 40 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | 21-Day period as one course. Cisplatin 60mg/m2 and pemetrexed 500mg/m2 on Day1. Repeat for 3 courses Within 6 weeks after the last day of the chemotherapy, it operates extrapleural pneumonectomy. Within 12weeks after the extrapleural pneumonectomy, it starts radiation. It's hemithorax irradiation. Total 30 times, five times a week, 1.8Gy once a day. Total 54Gy. |
Outcome(s)
Primary Outcome | Complete resection rate with extrapleural pneumonectomy Mortality rate |
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Secondary Outcome | Completion rate of trimodality therapy Disease-free survival (at 2 years) Overall survival (at 2 years) Response rate of induction chemotherapy Morbidity rate |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
Exclude 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. |
Related Information
Primary Sponsor | Hyogo College of Medicine |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Science and Technology AgencyMinistry of Education, Culture, Sports, Science and Technology |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | 0798-45-6088 |
choseihi@hyo-med.ac.jp | |
Affiliation | Japan Mesothelioma Research Center (JMRC) Japan Mesothelioma Research Center (JMRC) |
scientific contact | |
Name | Takashi Nakano |
Address | 1-1 Mukogawa-cho Nishinomiya City Hyogo Japan |
Telephone | |
Affiliation | Hyogo College of Medicine Division of Respiratory Medicine, Dept. of Internal Medicine |