A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma

A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma - A Feasibility Trial of Tri-modality Therapy for Resectable Malignant Pleural Mesothelioma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001154

Enrollment

Registered

2008-05-12

Start date

2008-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural mesothelioma

Interventions

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.

s hemithorax irradiation. Total 30 times, five times a week, 1.8Gy once a day. Total 54Gy.

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 and <75 7. Performance status of 0-1 (ECOG) 8. Predicted forced expiratory volume at 1 second after extrapleural pneumonectomy >=1L 9. Adequate major organ function as follows:1) Hb >=9.0g/dl2) Neutrohil count >=2,000/mm33) Platelet count >=100,000/mm34) Serum albumin >=3.0g/dl5) AST and ALT <=2.5times of upper limit6) Total bilirubin <=1.5times of upper limit7) Serum creatinine <1.2mg/dl8) SpO2(or SaO2) at FiO20.21 >=95%9) No adnormal finding on ECG10) Creratinine clearance >=60mL/min 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. 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.

Design outcomes

Primary

Measure	Time frame
Complete resection rate with extrapleural pneumonectomy Mortality rate	—

Secondary

Measure	Time frame
Completion rate of trimodality therapy Disease-free survival (at 2 years) Overall survival (at 2 years) Response rate of induction chemotherapy Morbidity rate	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026