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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01736 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| JCCCID552 | Other Identifier | Jonsson Comprehensive Cancer Center | |
| 15-000487 | Other Identifier | UCLA / Jonsson Comprehensive Cancer Center |
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slow enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (hypofractionated IMRT, pleurectomy/decortication) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Therapy | Radiation | Undergo accelerated hypofractionated IMRT |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Local Control (LC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Percy Lee | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
Eligibility screening by the Jonsson Comprehensive Cancer Center Data Safety Monitoring Board. Subjects undergo 5 fractions of hypofractionationated Intensity Modulated Radiation Therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease.Subjects then undergo pleurectomy/decortication within 14 days after completion of IMRT.
From 10/2015 to 04/2018, 2 subjects were consented into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo pleurectomy/decortication |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Intensity-Modulated Radiation Therapy | Radiation | Undergo accelerated hypofractionated IMRT |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Therapeutic Conventional Surgery | Procedure | Undergo pleurectomy/decortication |
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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 |
| Overall Survival (OS) | No data displayed because Outcome Measure has zero total participants analyzed. | Up to 5 years post-treatment |
| Pathologic Complete Response Rate (pCR) | No data displayed because Outcome Measure has zero total participants analyzed. | Up to 5 years post-treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo pleurectomy/decortication |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data was not collected | Posted | Up to 1 year |
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| 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. | Data was not collected | Posted | Up to 3 months |
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| 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. | Data was not collected | Posted | Up to 5 years post-treatment |
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| 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. | No data was collected | Posted | Up to 5 years post-treatment |
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| 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. | No data was collected | Posted | Up to 5 years post-treatment |
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| Secondary | Overall Survival (OS) | No data displayed because Outcome Measure has zero total participants analyzed. | Data was not collected | Posted | Up to 5 years post-treatment |
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| Secondary | Pathologic Complete Response Rate (pCR) | No data displayed because Outcome Measure has zero total participants analyzed. | Data was not collected | Posted | Up to 5 years post-treatment |
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Adverse event data was collected from 10/2015 until 4/2018, 30 months.
Dose limiting toxicity (DLT) defined as any treatment-related grade 3 or higher toxicity in the following categories: respiratory, upper GI, and cardiac. Also, any other grade 4 or 5 toxicity attributed to the therapy constitutes DLT. All AE's and SAE's, with grade and attribution were submitted to our DSMB as part of our quarterly summary reports. Serious adverse events were also reported individually to the DSMB and, where required, to our UCLA IRB within 2-10 days of awareness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo pleurectomy/decortication | 2 | 2 | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Expired from respiratory failure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Weakness | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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Due to the rarity of malignant pleural mesothelioma only two patients were enrolled and treated. There number as insufficient for any analysis.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Percy Lee | Jonsson Comprehensieve Cancer Center | 310 825-9771 | percylee@mednet.ucla.edu |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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