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

Brief 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.

Tracking Information
First Received DateNovember 2, 2015
Last Changed DateAugust 24, 2017
Start DateSeptember 1, 2015
Anticipated Primary Completion DateSeptember 1, 2018
Primary Outcome Measures

Ability to accrue sufficient patients to draw conclusions about endpoints in a timely and expedient manner [Time Frame: Up to 1 year]

Incidence of acute and subacute toxicity defined as grade 4 or 5 adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [Time Frame: Up to 3 months]

Incidence of chronic toxicity as assessed by the NCI CTCAE version 4.0 [Time Frame: Up to 5 years post-treatment]

Secondary Outcome Measures

Disease Specific Survival (DSS) [Time Frame: Up to 5 years post-treatment]

Local Control (LC) [Time Frame: Up to 5 years post-treatment]

Overall Survival (OS) [Time Frame: Up to 5 years post-treatment]

pathologic Complete Response Rate (pCR) [Time Frame: Up to 5 years post-treatment]

Descriptive Information
PhaseN/A
Study TypeInterventional
Condition
  • Pleural Epithelioid Mesothelioma
  • Pleural Malignant Mesothelioma
Intervention
  • Radiation: Hypofractionated Radiation Therapy
  • Radiation: Intensity-Modulated Radiation Therapy
  • Other: Laboratory Biomarker Analysis
  • Procedure: Therapeutic Conventional Surgery
Study Arms / Comparison Groups1 / 0
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.

Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment10
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Percy Lee, M.D.
Email: PercyLee@mednet.ucla.edu
Phone: 310-825-9775
Eligibility Criteria

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

Administrative Information
NCTIDNCT02672033
Responsible Party,
SponsorJonsson Comprehensive Cancer Center
Verification DateAugust 2017
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