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

NCT ID: NCT02672033

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2018-07-17

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (hypofractionated IMRT, pleurectomy/decortication)

Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT.

Group Type: EXPERIMENTAL

Hypofractionated Radiation Therapy

Intervention Type: RADIATION

Undergo accelerated hypofractionated IMRT

Intensity-Modulated Radiation Therapy

Intervention Type: RADIATION

Undergo accelerated hypofractionated IMRT

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Undergo pleurectomy/decortication

Interventions

Hypofractionated Radiation Therapy

Undergo accelerated hypofractionated IMRT

Intervention Type: RADIATION

Intensity-Modulated Radiation Therapy

Undergo accelerated hypofractionated IMRT

Intervention Type: RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Therapeutic Conventional Surgery

Undergo pleurectomy/decortication

Intervention Type: PROCEDURE

Other Intervention Names

Hypofractionated Radiotherapy; hypofractionation; IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Percy Lee

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2015-01736

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCCCID552

Identifier Type: OTHER

Identifier Source: secondary_id

15-000487

Identifier Type: OTHER

Identifier Source: secondary_id

15-000487

Identifier Type: -

Identifier Source: org_study_id