Skip to content

Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma.

Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma. - Phase I/II study/IMRT/trimodality therapy for MPM

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002217
Enrollment
13
Registered
2009-07-16
Start date
2009-08-01
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

Intensity-modurated radiotherapy(IMRT), using 6-10MV X-ray, daily 1.8Gy, 5 days/week until 50.4Gy, but for margin-positive lesions simultaneously boosted to 59.4Gy, after extrapleural pneumonectomy an

Sponsors

Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed malignant pleural mesothelioma, any subtypes. 2.Clinical stage I-III, completely resected 3.Several courses of chemotherapy with CDDP and pemetrexed are previously performed. 4.Age <75 5.ECOG PS 0-1 6.Patients with normal contralateral renal function. 7.Patients with no other serious organ dysfunction 8.Patients must sign a study-specific consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with any previous thoracic surgery not intend to complete resection or chemotherapy except for CDDP/pemetrexed. 2.Patients with no adequate reconstoration of diaphragma. 3.Active another neoplasm or previous (wihin 5 years) malignansies 4.Previous radiotherapy to the chest 5.Serious heart disease, arrhythmia, hypofunction of residual lung, uncontrolled infection, pyschological difficulty 6.Uncontrolled diabetes, any complications need steroids therapies. 7.Not suitable for participating in the study for any reasons

Design outcomes

Primary

MeasureTime frame
Phase I: Adverse events within 180 days after IMRT. Phase II: Relapse-free survival

Secondary

MeasureTime frame
treatment(radiation therapy) completion rate, pattern of recurrence, overall survival

Countries

Japan

Outcome results

None listed

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