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

Inclusion Criteria:

- Histologically confirmed epithelioid predominantly (> 70%) subtype malignant pleural
mesothelioma

- Patient must have been evaluated by a University of California Los Angeles (UCLA)
thoracic surgeon, and deemed medically and technically suitable for a
pleurectomy/decortication procedure

- Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG)
0-2

- If a woman is of childbearing potential, a negative urine or serum pregnancy test
must be documented; women of childbearing potential must agree to use adequate
contraception (hormonal or barrier method of birth control; or abstinence) for
duration of study participation and for up to 4 weeks following the study

Exclusion Criteria:

- Patients who have previously received therapeutic radiation therapy to the chest

- Active systemic, pulmonary, or pericardial infection

- Use of chemotherapy within 4 weeks of the planned start of radiation therapy

- Pregnant women, or women of childbearing potential who are sexually active and not
willing/able to use medically acceptable forms of contraception for the entire study
period and for up to 4 weeks after the study

- Refusal to sign the informed consent

- Patients who are participating in a concurrent treatment protocol