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

UMIN ID: UMIN000002217

Registered date:16/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Malignant Pleural Mesothelioma
• Date of first enrollment: 2009/08/01
• Target sample size: 13
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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 and chemotherapy w/CDDP and pemetrexed.

Outcome(s)

• Primary Outcome: Phase I: Adverse events within 180 days after IMRT. Phase II: Relapse-free survival
• Secondary Outcome: treatment(radiation therapy) completion rate, pattern of recurrence, overall survival

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Hospital
• Secondary Sponsor: None
• Source(s) of Monetary Support: applying,None