Pleural Epithelioid Mesothelioma, Pleural Malignant Mesothelioma
Conditions
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.
Interventions
RADIATIONHypofractionated Radiation Therapy
Undergo accelerated hypofractionated IMRT
RADIATIONIntensity-Modulated Radiation Therapy
Undergo accelerated hypofractionated IMRT
OTHERLaboratory Biomarker Analysis
Correlative studies
PROCEDURETherapeutic Conventional Surgery
Undergo pleurectomy/decortication
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0 | Up to 5 years post-treatment | No data displayed because Outcome Measure has zero total participants analyzed. |
| Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner | Up to 1 year | No data displayed because Outcome Measure has zero total participants analyzed. |
| 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 | Up to 3 months | No data displayed because Outcome Measure has zero total participants analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Specific Survival (DSS) | Up to 5 years post-treatment | Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed. |
| Pathologic Complete Response Rate (pCR) | Up to 5 years post-treatment | No data displayed because Outcome Measure has zero total participants analyzed. |
| Local Control (LC) | Up to 5 years post-treatment | Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed. |
| Overall Survival (OS) | Up to 5 years post-treatment | No data displayed because Outcome Measure has zero total participants analyzed. |
Countries
United States
Participant flow
Recruitment details
From 10/2015 to 04/2018, 2 subjects were consented into the trial.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 2 |
Baseline characteristics
| Characteristic | Treatment (Hypofractionated IMRT, Pleurectomy/Decortication) |
|---|---|
| Age, Customized Age 63 Years | 1 Participants |
| Age, Customized Age 69 Years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 2 / 2 |
Outcome results
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.
Time frame: Up to 1 year
Population: Data was not collected
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.
Time frame: Up to 3 months
Population: Data was not collected
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.
Time frame: Up to 5 years post-treatment
Population: Data was not collected
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.
Time frame: Up to 5 years post-treatment
Population: No data was collected
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.
Time frame: Up to 5 years post-treatment
Population: No data was collected
Secondary
Overall Survival (OS)
No data displayed because Outcome Measure has zero total participants analyzed.
Time frame: Up to 5 years post-treatment
Population: Data was not collected
Secondary
Pathologic Complete Response Rate (pCR)
No data displayed because Outcome Measure has zero total participants analyzed.
Time frame: Up to 5 years post-treatment
Population: Data was not collected