Trial Outcomes & Findings for Evaluation of Single Session Stereotactic Body Radiotherapy (NCT NCT00492817)

NCT ID: NCT00492817

Last Updated: 2025-10-24

Results Overview

To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 71 participants
• Primary outcome timeframe: Six months after completion of radiation therapy
• Results posted on: 2025-10-24

Participant Flow

Participant milestones

Measure	Single Session Stereotactic Body Radiotherapy (SBRT) On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Stereotactic Body Radiotherapy: On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Single Session Stereotactic Body Radiotherapy

Baseline characteristics by cohort

Measure	Single Session Stereotactic Body Radiotherapy (SBRT) n=71 Participants On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Stereotactic Body Radiotherapy: On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	50 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	4 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	71 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months after completion of radiation therapy

To measure 6-month complete pain relief, i.e., 6-month "pain worst" from the BPI being zero

Outcome measures

Measure

Single Session Stereotactic Body Radiotherapy (SBRT) n=61 Participants On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Stereotactic Body Radiotherapy: On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.

Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and Para- Spinal Tumors in a Single Session

18 Participants

PRIMARY outcome

Timeframe: local tumor control rate, the time frame is up to 48 months

Local tumor control rate as measured based on spinal MRI showing absence of progression

Outcome measures

Measure

Single Session Stereotactic Body Radiotherapy (SBRT) n=61 Participants On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Stereotactic Body Radiotherapy: On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.

Local Tumor Control Rate

48 Participants

PRIMARY outcome

Timeframe: Up to 24 months after radiation therapy

Evidence of paralysis (Grade 4 motor neuropathy) casued by radiation myelitis

Outcome measures

Measure

Single Session Stereotactic Body Radiotherapy (SBRT) n=61 Participants On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Stereotactic Body Radiotherapy: On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.

Paralysis (Grade 4 Motor Neuropathy)

0 Participants

Adverse Events

Single Session Stereotactic Body Radiotherapy (SBRT)

Serious events: 7 serious events

Other events: 0 other events

Deaths: 63 deaths

Serious adverse events

Measure	Single Session Stereotactic Body Radiotherapy (SBRT) n=71 participants at risk On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed. Stereotactic Body Radiotherapy: On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
Renal and urinary disorders Nephrostomy tube placement, Malfunctioning prostomy	1.4% 1/71 • Approximately 1 year, 9 months
Gastrointestinal disorders Esophageal stricture	2.8% 2/71 • Approximately 1 year, 9 months
Blood and lymphatic system disorders Hemorrhage	1.4% 1/71 • Approximately 1 year, 9 months
General disorders Diarrhea	2.8% 2/71 • Approximately 1 year, 9 months
Musculoskeletal and connective tissue disorders Neroforaminal stenosis and nerve root compression	1.4% 1/71 • Approximately 1 year, 9 months

Other adverse events

Adverse event data not reported

Additional Information

Amol J. Ghia, MD

The University of Texas MD Anderson Cancer Center

Phone: (832) 628-7357

Email: ajghia@mdanderson.org

Results disclosure agreements

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