Trial Outcomes & Findings for Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC) (NCT NCT01818986)
NCT ID: NCT01818986
Last Updated: 2022-05-06
Results Overview
To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee \[JNCI 92(3):205-216, 2000\] with modifications suggested by PCWG2 \[49\] recommendations and as used in the Phase III clinical trial by Kantoff et. al.\[10\]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
4 years
Results posted on
2022-05-06
Participant Flow
Participant milestones
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Baseline characteristics by cohort
| Measure |
Arm One
n=20 Participants
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
Sipuleucel-T
Stereotactic Ablative Body Radiation
|
|---|---|
|
Age, Customized
Age at Enrollment
|
69 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not Hispanic
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not Hispanic
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Baseline performance status
0
|
12 Participants
n=5 Participants
|
|
Baseline performance status
1
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsTo evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression will be evaluated in this study using the modified new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Committee \[JNCI 92(3):205-216, 2000\] with modifications suggested by PCWG2 \[49\] recommendations and as used in the Phase III clinical trial by Kantoff et. al.\[10\]. Changes in only the largest diameter (one-dimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria as outlined in http://www.recist.com/.
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=20 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Time to Progression
|
11.2 weeks
Interval 6.8 to 14.0
|
SECONDARY outcome
Timeframe: 6 weekTo evaluate the percentage of participants with Immune response at 6 weeks. Immune response will be measured using ELISpot assay (with PA2024). An immune endpoint will be reached by the patient if a \>100% increase in immune response is measured by ANY of the assays.
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=16 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Immune Response
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 60 monthsTo evaluate the improvement in the overall survival (OS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Overall survival (OS) was defined as the duration of time from the start of treatment to the time of death from any cause.
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=20 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Overall Survival (OS)
|
76.8 number of weeks
Interval 41.6 to 130.8
|
SECONDARY outcome
Timeframe: 4 yearsTo evaluate the improvement in the progression free survival (PFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Progression free survival (PFS) was defined as the length of time from the start of treatment to disease progression or death from any cause.
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=20 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Progression Free Survival (PFS)
|
10.4 number of weeks
Interval 6.4 to 13.9
|
SECONDARY outcome
Timeframe: 4 yearsTo evaluate the improvement in the biochemical progression free survival (bPFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Biochemical progression free survival was defined as the time from the beginning of treatment to PSA (prostate-specific antigen) disease progression. Biochemical progression was defined as an increase in PSA of \> 2 ng/ml from baseline and an increase of \> 25% from the baseline value and confirmed by a second measurement more than three weeks later.
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=20 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Biochemical Progression Free Survival (bPFS)
|
12.5 number of weeks
Interval 4.8 to 33.5
|
SECONDARY outcome
Timeframe: 4 yearsTo evaluate the improvement in the prostate cancer-specific survival (PCaSS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone. Prostate cancer-specific survival was defined as the percentage of patients who had not died from prostate cancer at the time of analysis
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=20 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Prostate Cancer-specific Survival (PCaSS)
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: 60 monthsTo evaluate the adverse events for the first 6 months after completion of radiation therapy associated with Sipuleucel-T when administered in combination with SABR to metastatic sites, as compared to the historically reported data with the treatment of Sipuleucel-T alone. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. Adverse events not specifically defined in the NCI CTCAE will be scored on the Adverse Event log according to the general guidelines provided by the NCI CTCAE and as outlined: Grade 1: Mild Grade 2: Moderate Grade 3: Severe or medically significant but not immediately life threatening Grade 4: Life threatening consequences Grade 5: Death related to the adverse event
Outcome measures
| Measure |
Sipuleucel-T and SABR (Stereotactic Ablative Body Radiation)
n=20 Participants
Sipuleucel-T (brand name Provenge) IV infusion and Stereotactic Ablative Body Radiation (SABR) dose varying from 21 Gy-33 Gy in 1-3 fractions.
|
|---|---|
|
Adverse Events
Grade 1
|
51 number of events
|
|
Adverse Events
Grade 2
|
8 number of events
|
|
Adverse Events
Grade 3
|
4 number of events
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: This data was not collected per protocol. The objective in question was intended to be an exploratory objective rather than a primary objective. However, due to an error in protocol modification, this change did not occur.
To evaluate the cost effectiveness and health-related quality adjusted life of the combination treatment of SABR and sipuleucel T in patients with mCRPC.
Outcome measures
Outcome data not reported
Adverse Events
Arm One
Serious events: 0 serious events
Other events: 20 other events
Deaths: 19 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm One
n=20 participants at risk
Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR)
Sipuleucel-T
Stereotactic Ablative Body Radiation
|
|---|---|
|
Investigations
Alkaline Phosphatase Increased
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Number of events 2 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
General disorders
Chills
|
15.0%
3/20 • Number of events 3 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
3/20 • Number of events 3 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Nervous system disorders
Extrapyramidal disorder
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Nervous system disorders
Fatigue
|
55.0%
11/20 • Number of events 11 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
General disorders
Fever
|
10.0%
2/20 • Number of events 2 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Nervous system disorders
Headaches
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Vascular disorders
Hot Flashes
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Investigations
Lymphocyte Count Decrease
|
10.0%
2/20 • Number of events 2 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Number of events 6 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
General disorders
Non-Cardiac Chest Pain
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Gastrointestinal disorders
Rectal Pain
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Gastrointestinal disorders
Rectal Urgency
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Vascular disorders
Thrombolic Event
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
5.0%
1/20 • Number of events 1 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Renal and urinary disorders
Urinary urgency
|
15.0%
3/20 • Number of events 3 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
3/20 • Number of events 3 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
|
Investigations
White blood cells decreased
|
10.0%
2/20 • Number of events 2 • 60 months. Each patient will be assessed for the development of toxicity for 6 months following the completion of radiation therapy and 60 months for overall survival.
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the adverse event
|
Additional Information
Dr. Raquibul Hannan
University of Texas Southwestern Medical Center Dallas
Phone: 214-645-7696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place