Trial Outcomes & Findings for Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies (NCT NCT02950025)
NCT ID: NCT02950025
Last Updated: 2019-04-03
Results Overview
* The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. * Grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment * Please note that the following statistical analysis was not performed due to small sample size: Statistical analysis will be powered to detect a reduction of toxicity from 35% Grade 3 or greater toxicity to 10% Grade 3 or greater toxicity using online-adaptive therapy. Statistical analysis will be one-sided test for independent proportions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Up through 6 months post-treatment (approximately 6 months and 2 weeks)
Results posted on
2019-04-03
Participant Flow
The study opened to participant enrollment on 01/19/2017 and closed to participant enrollment on 08/13/2018.
Participant milestones
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daily Online Adaptation Versus Localization for MRI-Guided SBRT for Unresectable Primary or Oligometastatic Abdominal Malignancies
Baseline characteristics by cohort
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
n=5 Participants
|
85 years
n=7 Participants
|
75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up through 6 months post-treatment (approximately 6 months and 2 weeks)* The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. * Grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment * Please note that the following statistical analysis was not performed due to small sample size: Statistical analysis will be powered to detect a reduction of toxicity from 35% Grade 3 or greater toxicity to 10% Grade 3 or greater toxicity using online-adaptive therapy. Statistical analysis will be one-sided test for independent proportions.
Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Number of Grade 3 or Greater Toxicity Occurring in Patients Receiving Online, Adaptive, MRI-guided SBRT to the Abdomen and in Patients Receiving Non-adaptive SBRT
|
0 adverse event
|
1 adverse event
|
SECONDARY outcome
Timeframe: At six month follow-up (approximately 6 months and 2 weeks)* Tumor response rate = rate of participants who have complete or partial response at the six month follow-up * Complete Response (CR): Disappearance of the target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR): At least a 30% decrease in the (sum of the) diameter of the target lesion(s), taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Tumor Response Rate
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At six month follow-up (approximately 6 months and 2 weeks)-up* PFS rate - the number of participants who have not progressed and/or died at the six-month follow-up * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology
Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Progression-free Survival (PFS) Rate
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At six month follow-up (approximately 6 months and 2 weeks)* Disease free survival rate = the number of participants who are disease free (without any signs or symptoms of cancer) at the six-month follow-up * Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology.
Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Disease Free Survival Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At six month follow-up (approximately 6 months and 2 weeks)* Overall survival rate - number of participants alive at the six-month follow-up * Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology.
Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Overall Survival (OS) Rate
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment, six-weeks post treatment, and six months post-treatment* Utilize both paired t-tests and repeated measures ANOVA to analyze QOL data (this was unable to be performed due to the small sample size) * The question asked the participant "how would you rate your quality of life during the past week?" * The scale ranges from 1=very poor to 7 = excellent. The higher the score the better the quality of life.
Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Patient Reported Overall Quality of Life During the Past Week as Measured by EORTC QLQ-C30 Quality of Life
Pre-treatment
|
5 score on a scale
Interval 5.0 to 5.0
|
5 score on a scale
Interval 2.0 to 6.0
|
|
Patient Reported Overall Quality of Life During the Past Week as Measured by EORTC QLQ-C30 Quality of Life
6-weeks post treatment
|
6 score on a scale
Interval 5.0 to 7.0
|
4 score on a scale
Interval 4.0 to 4.0
|
|
Patient Reported Overall Quality of Life During the Past Week as Measured by EORTC QLQ-C30 Quality of Life
6 months post treatment
|
6 score on a scale
Interval 6.0 to 6.0
|
3 score on a scale
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: At six month follow-up (approximately 6 months and 2 weeks)Outcome measures
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 Participants
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Number of Participants With Local Failure
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A: Online Non-adaptive MRI-guided SBRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B: Online-Adaptive MRI-guided SBRT
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 participants at risk
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 participants at risk
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
Other adverse events
| Measure |
Arm A: Online Non-adaptive MRI-guided SBRT
n=2 participants at risk
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
Arm B: Online-Adaptive MRI-guided SBRT
n=3 participants at risk
* All patients will be initially planned for stereotactic body radiation therapy to a minimum dose of 50Gy in five fractions to the planning target volume (PTV)
* Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments
* All patients will undergo both CT and MRI simulation in positioning appropriate for the specific treatment site
* When patients present for their first SBRT treatment session, the treating physician will evaluate their individual anatomy to determine if adaptive planning is indicated. Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day
* Quality of life questionnaire baseline, 6 weeks after treatment conclusion, and 6 months after treatment conclusion
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/2 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
33.3%
1/3 • Adverse events were tracked for 6 months following the last day of SBRT. Please note, only acute adverse events were tracked. For the purposes of this protocol, adverse events collected and documented are non-hematologic acute grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment.
|
Additional Information
Michael C. Roach, M.D.
Washington University School of Medicine
Phone: 314-747-1786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place