Trial Outcomes & Findings for SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma (NCT NCT01357525)
NCT ID: NCT01357525
Last Updated: 2021-11-24
Results Overview
Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2021-11-24
Participant Flow
Participant milestones
| Measure |
Stereotactic Body Radiotherapy
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiotherapy
n=50 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Age, Continuous
|
69.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 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
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=43 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Local Progression-free Survival (LPFS) at 1-year
|
85 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=43 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Local Progression-free Survival (LPFS) at 2-years
|
78.12 percentage of participants
Interval 57.82 to 93.06
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients without disease progression in target lesion from time from enrollment until one month. Death or development of distant disease is not regarded as an event. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Local Progression-free Survival (LPFS)
|
NA percentage of participants
Interval 41.0 to
Median not determined; upper bound not reached
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Time duration that patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Regional Progression-free Survival (RPFS)
|
NA months
Interval 27.0 to
Median not determined; Upper bound not reached.
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Regional Progression-free Survival (RPFS) at 2-years
|
72.2 percentage of participants
Interval 57.56 to 87.84
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients that did not experience distant metastasis. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Distant Metastasis-free Survival (DMFS) at 2 Years
|
49.69 percentage of participants
Interval 31.98 to 67.43
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients without distant disease metastasis (progression of disease beyond local target lesion).
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Distant Metastasis-free Survival (DMFS)
|
21 percentage of participants
Interval 12.0 to
Upper bound not reached.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and experienced acute grade 3 þ radiation toxicity.
Percentage of patients that experienced acute toxicity (defined as toxicity occurring within 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Acute Toxicities Associated With SBRT
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPercentage of patients that experienced late toxicity (defined as toxicity occurring after 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Late Toxicities Associated With SBRT
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
Percentage of patients that did not experience disease progression at 2 years. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
2-year Progression-free Survival (PFS)
|
32.79 percentage of participants
Interval 17.49 to 50.25
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Patients that received study treatment per protocol and were evaluable for response.
The time from enrollment to disease progression. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=49 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Time to Progression (TTP)
|
12 months
Interval 7.0 to 27.0
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe length of time from enrollment to confirmed death from any cause.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=50 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Overall Survival (OS)
|
18 months
Interval 13.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to 12 monthsPercentage of patients alive at 1-year (death from any cause).
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=50 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Overall Survival (OS) at 1-year
|
68 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: Participants enrolled in study.
Percentage of patients alive at 2-years (death from any cause).
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=50 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Overall Survival (OS) at 2-years
|
39.95 percentage of participants
Interval 24.44 to 56.68
|
SECONDARY outcome
Timeframe: Up to 24 months (before treatment (baseline), shortly after neo-adjuvant treatment, shortly after surgery, shortly after SBRT, shortly after Adjuvant treatment)Population: Patients that completed FACT-G Quality of Life surveys.
The FACT-G is a 27 item questionnaire that assesses physical, social/family, emotional, and functional well-being, provided to patients and self-administered prior to SBRT, after completion of SBRT, and at each follow-up. The survey takes 5 minutes to complete and employs as five-point scale from 0 (not at all) to 4 (very much). Subscale scores added to obtain total score. Scoring range is between 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better QoL.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy
n=22 Participants
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Quality of Life (QoL) FACT-G
Social/family well-being (SWB) - Shortly after surgery
|
25 score on a scale
Interval 23.0 to 28.0
|
|
Quality of Life (QoL) FACT-G
Functional well-being -Shortly after surgery
|
22 score on a scale
Interval 14.0 to 27.0
|
|
Quality of Life (QoL) FACT-G
Physical well-being (PWB) - Before treatment (baseline)
|
24 score on a scale
Interval 12.0 to 27.0
|
|
Quality of Life (QoL) FACT-G
Physical well-being (PWB) - Shortly after neo-adjuvant treatment
|
25 score on a scale
Interval 23.0 to 27.0
|
|
Quality of Life (QoL) FACT-G
Physical well-being (PWB) - Shortly after surgery
|
24 score on a scale
Interval 21.0 to 25.0
|
|
Quality of Life (QoL) FACT-G
Physical well-being (PWB) - Shortly after SBRT
|
23 score on a scale
Interval 15.0 to 27.0
|
|
Quality of Life (QoL) FACT-G
Physical well-being (PWB) - Shortly after adjuvant treatment
|
18 score on a scale
Interval 9.0 to 26.0
|
|
Quality of Life (QoL) FACT-G
Social/family well-being (SWB) - Before treatment (baseline)
|
26 score on a scale
Interval 19.0 to 28.0
|
|
Quality of Life (QoL) FACT-G
Social/family well-being (SWB) - Shortly after neo-adjuvant treatment
|
28 score on a scale
Interval 28.0 to 28.0
|
|
Quality of Life (QoL) FACT-G
Social/family well-being (SWB) - Shortly after SBRT
|
26 score on a scale
Interval 20.0 to 28.0
|
|
Quality of Life (QoL) FACT-G
Social/family well-being (SWB) - Shortly after adjuvant treatment
|
17 score on a scale
Interval 15.0 to 18.0
|
|
Quality of Life (QoL) FACT-G
Emotional well-being (EWB) - Before treatment (baseline)
|
17 score on a scale
Interval 16.0 to 19.0
|
|
Quality of Life (QoL) FACT-G
Emotional well-being (EWB) - Shortly after neo-adjuvant
|
22 score on a scale
Interval 20.0 to 23.0
|
|
Quality of Life (QoL) FACT-G
Emotional well-being (EWB) -Shortly after surgery
|
20 score on a scale
Interval 16.0 to 22.0
|
|
Quality of Life (QoL) FACT-G
Emotional well-being (EWB) -Shortly after SBRT
|
21 score on a scale
Interval 17.0 to 22.0
|
|
Quality of Life (QoL) FACT-G
Emotional well-being (EWB) - Shortly after adjuvant treatment
|
14 score on a scale
Interval 12.0 to 16.0
|
|
Quality of Life (QoL) FACT-G
Functional well-being (FWB) - Before treatment (baseline)
|
14 score on a scale
Interval 5.0 to 23.0
|
|
Quality of Life (QoL) FACT-G
Functional well-being (FWB) - Shortly after neo-adjuvant
|
20 score on a scale
Interval 11.0 to 28.0
|
|
Quality of Life (QoL) FACT-G
Functional well-being (FWB) Shortly after SBRT
|
13 score on a scale
Interval 11.0 to 21.0
|
|
Quality of Life (QoL) FACT-G
Functional well-being (FWB) Shortly after adjuvant treatment
|
17 score on a scale
Interval 13.0 to 20.0
|
|
Quality of Life (QoL) FACT-G
Total score - Before treatment (baseline)
|
83 score on a scale
Interval 52.0 to 95.0
|
|
Quality of Life (QoL) FACT-G
Total score - Shortly after neo-adjuvant
|
94 score on a scale
Interval 82.0 to 106.0
|
|
Quality of Life (QoL) FACT-G
Total score - Shortly after surgery
|
85 score on a scale
Interval 77.0 to 94.0
|
|
Quality of Life (QoL) FACT-G
Total score - Shortly after SBRT
|
78 score on a scale
Interval 73.0 to 89.0
|
|
Quality of Life (QoL) FACT-G
Total score - Shortly after adjuvant treatment
|
64 score on a scale
Interval 53.0 to 76.0
|
Adverse Events
Stereotactic Body Radiotherapy
Serious events: 0 serious events
Other events: 23 other events
Deaths: 25 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stereotactic Body Radiotherapy
n=49 participants at risk
Stereotactic Body Radiation Therapy (SBRT): An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
12 Gy x 3 fractions (36 Gy total)
|
|---|---|
|
Gastrointestinal disorders
Abd drain
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Abdom pain
|
6.1%
3/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Abx diarrhea
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Dehydration
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Delayed gastric emptying
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Psychiatric disorders
Delirium.
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
3/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Fatigue
|
16.3%
8/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Fever
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
GI bleed
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Hepatic bleeding
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Hair thinning
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Hand foot syndrome
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Vascular disorders
Hematoma
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
HHNK
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Hyperglycemia (grade 3)
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
Leukopenia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Lip herpetic lesion
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Malaise
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Nervous system disorders
Neuropathy
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
General disorders
Neutronic fever
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
Neutropenia
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
NG tube
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Obstruction (grade 3)
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Hepatobiliary disorders
Pancreatic leak
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Cardiac disorders
PE
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Nervous system disorders
Peripheral neuropathy
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Respiratory, thoracic and mediastinal disorders
PNA
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Musculoskeletal and connective tissue disorders
Right sided weakness,
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Skin and subcutaneous tissue disorders
Skin
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Nervous system disorders
SMA pseudoaneurysm
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Hepatobiliary disorders
SMA pseudocyst
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Nervous system disorders
SMA pseuoanuersym
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Vascular disorders
SMV thrombus
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Infections and infestations
Strep viridans bacteremia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Blood and lymphatic system disorders
Thrombotypenia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Upper GI leak
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Infections and infestations
UTI
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Metabolism and nutrition disorders
Volume depletion
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Investigations
Weight loss
|
4.1%
2/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
|
Gastrointestinal disorders
Xerstomia
|
2.0%
1/49 • Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
|
Additional Information
Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place