Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02672033|
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pleural Epithelioid Mesothelioma Pleural Malignant Mesothelioma||Radiation: Hypofractionated Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Procedure: Therapeutic Conventional Surgery||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma: A Pilot Study|
|Actual Study Start Date :||September 1, 2015|
|Estimated Primary Completion Date :||September 1, 2018|
|Estimated Study Completion Date :||September 1, 2019|
Experimental: 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.
Radiation: Hypofractionated Radiation Therapy
Undergo accelerated hypofractionated IMRT
Radiation: Intensity-Modulated Radiation Therapy
Undergo accelerated hypofractionated IMRT
Other: Laboratory Biomarker Analysis
Procedure: Therapeutic Conventional Surgery
- Ability to accrue sufficient patients to draw conclusions about endpoints in a timely and expedient manner [ Time Frame: Up to 1 year ]The goal sample size will be 10 patients.
- 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 ]
- Disease Specific Survival (DSS) [ Time Frame: Up to 5 years post-treatment ]Cumulative incidence approach will be used to estimate DSS.
- Local Control (LC) [ Time Frame: Up to 5 years post-treatment ]Cumulative incidence approach will be used to estimate the local failure rates.
- Overall Survival (OS) [ Time Frame: Up to 5 years post-treatment ]
- pathologic Complete Response Rate (pCR) [ Time Frame: Up to 5 years post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672033
|Contact: Percy Lee, M.D.||310-825-9775||PercyLee@mednet.ucla.edu|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Percy P. Lee 310-825-9775 PercyLee@mednet.ucla.edu|
|Principal Investigator: Percy Lee|
|Principal Investigator:||Percy Lee||UCLA / Jonsson Comprehensive Cancer Center|