NCT02672033

Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma

Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pleural Epithelioid Mesothelioma
• Pleural Malignant Mesothelioma

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Undergo accelerated hypofractionated IMRT
RADIATION	Intensity-Modulated Radiation Therapy	Undergo accelerated hypofractionated IMRT
OTHER	Laboratory Biomarker Analysis	Correlative studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo pleurectomy/decortication

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-24
• Completion: 2018-07-17
• First posted: 2016-02-03
• Last updated: 2020-07-24
• Results posted: 2020-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study