Trial Outcomes & Findings for A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy (NCT NCT01624220)
NCT ID: NCT01624220
Last Updated: 2026-05-12
Results Overview
Patients will be monitored at each follow-up visit, with MRI of the spine performed at each follow-up time point during the first year. Treated lesions will be classified as progressive (defined as \> 25% increased volume), stable (defined as radiographically unchanged), or smaller, and spinal tumor progression-free survival (PFS) will be calculated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
10 years and 9.5 months
Results posted on
2026-05-12
Participant Flow
A total of 41 patient enrolled to this study from Aug 3, 2012 to Jun 1, 2015. Stage 1 in 38 patient and stage 2 in 3 patients
Participant milestones
| Measure |
Stage 2
Stage 2 has group 3 with the patient population of T4-T10
|
Stage 1
Stage 1 has 5 groups, Group 1 has the patient population on T4-T12, Group 2 has the patient population of L1-L5, group 5 has the patient population of C5-T13, group 6 has patient population of T4-T12, group 7 has the patient population of L1-L5
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
38
|
|
Overall Study
COMPLETED
|
3
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Stage 2
Stage 2 has group 3 with the patient population of T4-T10
|
Stage 1
Stage 1 has 5 groups, Group 1 has the patient population on T4-T12, Group 2 has the patient population of L1-L5, group 5 has the patient population of C5-T13, group 6 has patient population of T4-T12, group 7 has the patient population of L1-L5
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
Baseline characteristics by cohort
| Measure |
Stage 1
n=38 Participants
Stage 1 has 5 groups, Group 1 has the patient population on T4-T12, Group 2 has the patient population of L1-L5, group 5 has the patient population of C5-T13, group 6 has patient population of T4-T12, group 7 has the patient population of L1-L5
|
Stage 2
n=3 Participants
Stage 2 has group 3 with the patient population of T4-T10
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
26 Participants
n=2016 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
15 Participants
n=2016 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
18 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
23 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
6 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
12 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
23 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
1 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
2 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=1512 Participants
|
2 Participants
n=504 Participants
|
31 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1512 Participants
|
1 Participants
n=504 Participants
|
5 Participants
n=2016 Participants
|
|
Region of Enrollment
United States
|
38 participants
n=1512 Participants
|
3 participants
n=504 Participants
|
41 participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: 10 years and 9.5 monthsPatients will be monitored at each follow-up visit, with MRI of the spine performed at each follow-up time point during the first year. Treated lesions will be classified as progressive (defined as \> 25% increased volume), stable (defined as radiographically unchanged), or smaller, and spinal tumor progression-free survival (PFS) will be calculated.
Outcome measures
| Measure |
Stage 1
n=38 Participants
Stage 1 has 5 groups, Group 1 has the patient population on T4-T12, Group 2 has the patient population of L1-L5, group 5 has the patient population of C5-T13, group 6 has patient population of T4-T12, group 7 has the patient population of L1-L5
|
Stage 2
n=3 Participants
Stage 2 has group 3 with the patient population of T4-T10
|
|---|---|---|
|
Overall Response at Protocol Treatment Site
Stable disease
|
23 Participants
|
2 Participants
|
|
Overall Response at Protocol Treatment Site
Progression disease
|
7 Participants
|
0 Participants
|
|
Overall Response at Protocol Treatment Site
Unknown
|
8 Participants
|
1 Participants
|
Adverse Events
Stage 1
Serious events: 0 serious events
Other events: 10 other events
Deaths: 18 deaths
Stage 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stage 1
n=38 participants at risk
Stage 1 has 5 groups, Group 1 has the patient population on T4-T12, Group 2 has the patient population of L1-L5, group 5 has the patient population of C5-T13, group 6 has patient population of T4-T12, group 7 has the patient population of L1-L5
|
Stage 2
n=3 participants at risk
Stage 2 has group 3 with the patient population of T4-T10
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest pain, abdominal pain
|
0.00%
0/38 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
33.3%
1/3 • Number of events 1 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Musculoskeletal and connective tissue disorders
weakness / DC diagnoses: new epidural disease
|
2.6%
1/38 • Number of events 1 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Metabolism and nutrition disorders
Cathecholamine excess (causing severe swings in BP and obstipation)
|
2.6%
1/38 • Number of events 1 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Gastrointestinal disorders
Failure to thrive
|
2.6%
1/38 • Number of events 1 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
General disorders
Fever
|
5.3%
2/38 • Number of events 2 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot drop
|
2.6%
1/38 • Number of events 1 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Gastrointestinal disorders
GI bleed
|
2.6%
1/38 • Number of events 1 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.6%
1/38 • Number of events 2 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
|
Nervous system disorders
pain
|
5.3%
2/38 • Number of events 4 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
0.00%
0/3 • From date of protocol registration until the date of documented development of AEs in both treatment groups (sate 1 and Stage 2), assessed in every visit, approximately 3 years and 7 days
Only grade 2 and above toxicity that is directly related to therapy will be required to be documented related to treatment occurring within one month of treatment.
|
Additional Information
Dr. Amol Jitendra Ghia
University of Texas MD Anderson Cancer Center
Phone: (832) 628-7357
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place