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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02672033
• Other study ID #: 15-000487
• Secondary ID: NCI-2015-01736JC
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: July 17, 2018

Study information

• Verified date: May 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 17, 2018
• Est. primary completion date: May 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Pleural Epithelioid Mesothelioma
• Pleural Malignant Mesothelioma

Intervention

Radiation:
• Hypofractionated Radiation Therapy
Undergo accelerated hypofractionated IMRT
• Intensity-Modulated Radiation Therapy
Undergo accelerated hypofractionated IMRT

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Therapeutic Conventional Surgery
Undergo pleurectomy/decortication

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 1 year
Primary	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	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 3 months
Primary	Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 5 years post-treatment
Secondary	Disease Specific Survival (DSS)	Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.	Up to 5 years post-treatment
Secondary	Local Control (LC)	Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.	Up to 5 years post-treatment
Secondary	Overall Survival (OS)	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 5 years post-treatment
Secondary	Pathologic Complete Response Rate (pCR)	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 5 years post-treatment