Trial Outcomes & Findings for Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma (NCT NCT02672033)

Results Overview

No data displayed because Outcome Measure has zero total participants analyzed.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2020-07-24

Participant Flow

From 10/2015 to 04/2018, 2 subjects were consented into the trial.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Hypofractionated IMRT, Pleurectomy/Decortication) n=2 Participants 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
Age, Customized Age · 63 Years	1 Participants n=5 Participants
Age, Customized Age · 69 Years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Data was not collected

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 3 months

Population: Data was not collected

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 5 years post-treatment

Population: Data was not collected

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post-treatment

Population: No data was collected

Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post-treatment

Population: No data was collected

Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post-treatment

Population: Data was not collected

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post-treatment

Population: Data was not collected

No data displayed because Outcome Measure has zero total participants analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Hypofractionated IMRT, Pleurectomy/Decortication)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Hypofractionated IMRT, Pleurectomy/Decortication) n=2 participants at risk 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
Respiratory, thoracic and mediastinal disorders Death	100.0% 2/2 • Number of events 2 • 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.

Other adverse events

Other adverse events
Measure	Treatment (Hypofractionated IMRT, Pleurectomy/Decortication) n=2 participants at risk 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
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • 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.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1 • 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.
General disorders Weakness	50.0% 1/2 • Number of events 1 • 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.

Additional Information

Dr. Percy Lee

Jonsson Comprehensieve Cancer Center

Phone: 310 825-9771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place