Trial Outcomes & Findings for Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients (NCT NCT02528942)

NCT ID: NCT02528942

Last Updated: 2021-07-22

Results Overview

To assess safety, investigators will evaluate the rate of grade 2 or higher (grade 2+) radiation pneumonitis as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: Up to 14 months
• Results posted on: 2021-07-22

Participant Flow

Participant milestones

Measure	Radiation Therapy The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Overall Study STARTED	101
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Measure	Radiation Therapy The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Overall Study Did not meet imaging criteria	9
Overall Study Lost to Follow-up	25

Baseline Characteristics

Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients

Baseline characteristics by cohort

Measure	Radiation Therapy n=67 Participants The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	64 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
Karnofsky Performance Scale (KPS)	90 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: Up to 14 months

To assess safety, investigators will evaluate the rate of grade 2 or higher (grade 2+) radiation pneumonitis as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.

Outcome measures

Measure	Radiation Therapy n=67 Participants The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System	10 Participants

SECONDARY outcome

Timeframe: Up to 14 months

The percentage will be calculated by taking the ratio of patients that had lung function profiles suitable for functional avoidance and patients that were clinically eligible (receiving 45-75 Gy).

Outcome measures

Measure	Radiation Therapy n=67 Participants The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance	9 Participants

Adverse Events

Radiation Therapy

Serious events: 10 serious events

Other events: 8 other events

Deaths: 12 deaths

Serious adverse events

Measure	Radiation Therapy n=67 participants at risk The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.5% 1/67 • Number of events 1 • 1 year
Gastrointestinal disorders Espophagitis	3.0% 2/67 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Chest pain	1.5% 1/67 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Shortness of breath	1.5% 1/67 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/67 • Number of events 1 • 1 year
Infections and infestations fever	1.5% 1/67 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders hemoptysis	1.5% 1/67 • Number of events 1 • 1 year
Nervous system disorders near syncope	1.5% 1/67 • Number of events 1 • 1 year
Gastrointestinal disorders Weight loss	1.5% 1/67 • Number of events 1 • 1 year

Other adverse events

Measure	Radiation Therapy n=67 participants at risk The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days. Radiation therapy: Radiation therapy will be given to study patients.
Gastrointestinal disorders Esophagitis	7.5% 5/67 • Number of events 5 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.5% 3/67 • Number of events 3 • 1 year

Additional Information

Yevgeniy Vinogradskiy PhD

Thomas Jefferson University

Phone: 2159553605

Email: yevgeniy.vinogradskiy@Jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place