Trial Outcomes & Findings for Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT) (NCT NCT01511081)

Results Overview

Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

2 years

Results posted on

2017-12-07

Participant Flow

Recruitment Period: August 28, 2012 to August 31, 2015. Recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 21 participants enrolled, four were excluded from the study before assignment to groups.

Participant milestones

Participant milestones
Measure	SBRT (Stereotactic Body Radiotherapy) 50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.	SBPT (Stereotactic Body Proton Therapy) 50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
Overall Study STARTED	8	9
Overall Study COMPLETED	8	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT (Stereotactic Body Radiotherapy) n=8 Participants 50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.	SBPT (Stereotactic Body Proton Therapy) n=9 Participants 50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.	Total n=17 Participants Total of all reporting groups
Age, Continuous	77 years n=5 Participants	72 years n=7 Participants	74 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Early study termination. Inadequate enrollment and study period to complete analysis per protocol.

Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Early study termination. Inadequate enrollment and study period to complete analysis per protocol.

Prospective assessment of positron emission tomography (PET) standardized uptake value (SUV) changes as a measure of treatment response and outcomes. Pulmonary function changes as a function of treatment and response.

Outcome measures

Outcome data not reported

Adverse Events

SBRT (Stereotactic Body Radiotherapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SBPT (Stereotactic Body Proton Therapy)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SBRT (Stereotactic Body Radiotherapy) n=8 participants at risk 50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.	SBPT (Stereotactic Body Proton Therapy) n=9 participants at risk 50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
Respiratory, thoracic and mediastinal disorders Metastatic squamous cell carcinoma of the lung	0.00% 0/8 • Adverse events will be evaluated weekly during the course of treatment, four treatments of SBRT or SBPT expected.	11.1% 1/9 • Number of events 1 • Adverse events will be evaluated weekly during the course of treatment, four treatments of SBRT or SBPT expected.

Other adverse events

Adverse event data not reported

Additional Information

Joe Chang, MD/Professor, Radiation Oncology Department

UT MD Anderson Cancer Center

Phone: 713-792-7734

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place