NIPH Clinical Trials Search

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
Health condition(s) or Problem(s) studiedMalignant pleural mesothelioma
Date of first enrollment2008/05/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
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.


Primary OutcomeComplete resection rate with extrapleural pneumonectomy Mortality rate
Secondary OutcomeCompletion 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 minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1. 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


public contact
Address Japan
Telephone 0798-45-6088
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
Affiliation Hyogo College of Medicine Division of Respiratory Medicine, Dept. of Internal Medicine