Pleural Malignant Mesothelioma Clinical Trial
Official title:
Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study
This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin layer of tissue that covers the lungs and lines the interior wall of the chest cavity). Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Hypofractionated radiation therapy is a type of radiation therapy in which the total prescribed dose of radiation is divided into fewer but larger doses as compared to conventional radiation therapy. Giving accelerated hypofractionated radiation therapy immediately before surgery may improve survival, and may also reduce side effects experienced by patients with pleural mesothelioma.
PRIMARY OBJECTIVES:
I. To determine the feasibility and toxicity (both acute and chronic) of accelerated
hypofractionated neoadjuvant helical intensity modulated radiation therapy prior to
pleurectomy/decortication for malignant pleural mesothelioma.
SECONDARY OBJECTIVES:
I. To determine the pathologic complete response rate (pCR). II. To determine the tumor local
control rate (LC). III. To determine the malignant pleural mesothelioma disease specific
survival (DSS).
IV. To determine the overall survival (OS). V. To assess transforming growth factor beta
(TGF-B), interleukin (IL)-1, and IL-6 levels as predictive biomarkers for treatment induced
tissue injury.
VI. To assess the changes in the postoperative pleural immunological milieu in terms of
chemo- and cytokine expression.
OUTLINE:
Patients undergo 5 fractions of accelerated hypofractionated intensity-modulated radiation
therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease. Patients then
undergo pleurectomy/decortication within 14 days after completion of IMRT.
After completion of study treatment, patients are followed up at 6 weeks, and then every 3
months for 5 years.
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