Trial Outcomes & Findings for Hypofractionated Stereotactic Body Radiation Therapy (SBRT) (NCT NCT01288534)
NCT ID: NCT01288534
Last Updated: 2017-10-24
Results Overview
To evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks. Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months.
COMPLETED
PHASE2
68 participants
24 months
2017-10-24
Participant Flow
Participant milestones
| Measure |
Radiation Treatment
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Overall Study
STARTED
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68
|
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Overall Study
COMPLETED
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68
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hypofractionated Stereotactic Body Radiation Therapy (SBRT)
Baseline characteristics by cohort
| Measure |
Radiation Treatment
n=68 Participants
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Age, Continuous
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63 years
n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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68 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 24 monthsTo evaluate the safety of the proposed hyperfractionation regimen of 5 fractions of radiation to treat prostate cancer with guidance of radiation using the Calypso 4D Treatment System (Calypso, and to compare it to that expected from conventional treatment, which would involve 40-42 smaller radiation fractions over 8-9 weeks. Percentage of patients with a MDD in Quality of Life (QOL) surveys for urinary incontinence (UI), urinary obstructive (UO), bowel (BS), and sexual (SS) domains were reviewed at 6 months and 24 months.
Outcome measures
| Measure |
Radiation Treatment
n=68 Participants
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
UO by MDD, 24 Months, n=36
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19 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
BS by MDD, 6 Months, n=45
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33 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
BS by MDD, 24 Months, n=31
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23 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
SS by MDD, 6 Months, n=44
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39 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
SS by MDD, 24 Months, n=35
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43 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
UI by MDD, 6 Months, n=46
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17 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
UI by MDD, 24 Months, n=34
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18 percentage of patients
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Percentage of Patients With a Minimally Detected Decline (MDD) in Quality of Life (QOL)
UO by MDD, 6 Months, n=46
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41 percentage of patients
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SECONDARY outcome
Timeframe: 1 YearTo estimate one year prostate specific antigen (PSA)control of prostate cancer when treated with stereotactic body radiotherapy (SBRT) using continuous real-time evaluation of prostate motion.
Outcome measures
| Measure |
Radiation Treatment
n=68 Participants
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Percentage of Patients With a PSA Nadir of <3.35 ng/ml at 12 Months
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89 percentage of patients
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SECONDARY outcome
Timeframe: 5 yearsPopulation: Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed.
To look at the relation between dose distribution and toxicities and to determine if reconstructed delivered doses are more predictive of toxicity than planned doses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Data was not collected in full by some centers for their patients and these endpoints couldn't be analyzed
To determine the relation between reconstructed delivered dose distributions, accounting for prostate translation and rotation, and tumor control probabilities.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsTo assess the frequency of required interventions (interruptions) based on real-time prostate translations and rotations to verify that the proposed planning target volume(PTV) margins and action level are appropriate and practical. This will be assessed by the percentage of patients with no interventions for any fraction, the percentage of patients with 1-2 fractions interrupted and the percentage of patients with more than two fractions interrupted and the percentage of patients that had an interruption of the beam at least once for all 5 fractions.
Outcome measures
| Measure |
Radiation Treatment
n=68 Participants
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Frequency of Required Interventions.
No interruptions for any fraction
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24 percentage of participants
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Frequency of Required Interventions.
1-2 fractions interrupted
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23 percentage of participants
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Frequency of Required Interventions.
More than 2 fractions interrupted
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53 percentage of participants
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Frequency of Required Interventions.
At least 1 interruption for all 5 fractions
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24 percentage of participants
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Adverse Events
Radiation Treatment
Serious adverse events
| Measure |
Radiation Treatment
n=68 participants at risk
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Blood and lymphatic system disorders
Anemia
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1.5%
1/68 • Number of events 1
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Cardiac disorders
Cardiac disorders - Other
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2.9%
2/68 • Number of events 2
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Cardiac disorders
Restrictive cardiomyopathy
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1.5%
1/68 • Number of events 1
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Gastrointestinal disorders
Gastric ulcer
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1.5%
1/68 • Number of events 1
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Gastrointestinal disorders
Gastrointestinal disorders - Other
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1.5%
1/68 • Number of events 1
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Injury, poisoning and procedural complications
Fracture
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1.5%
1/68 • Number of events 1
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
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1.5%
1/68 • Number of events 1
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Other adverse events
| Measure |
Radiation Treatment
n=68 participants at risk
Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
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1.5%
1/68 • Number of events 1
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Gastrointestinal disorders
Constipation
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4.4%
3/68 • Number of events 3
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Gastrointestinal disorders
Diarrhea
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35.3%
24/68 • Number of events 28
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Gastrointestinal disorders
Fecal incontinence
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2.9%
2/68 • Number of events 2
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Gastrointestinal disorders
Flatulence
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1.5%
1/68 • Number of events 1
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Gastrointestinal disorders
Gastrointestinal disorders - Other
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10.3%
7/68 • Number of events 11
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Gastrointestinal disorders
Hemorrhoidal hemorrhage
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1.5%
1/68 • Number of events 1
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Gastrointestinal disorders
Nausea
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1.5%
1/68 • Number of events 2
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Gastrointestinal disorders
Proctitis
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26.5%
18/68 • Number of events 19
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Gastrointestinal disorders
Rectal hemorrhage
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7.4%
5/68 • Number of events 5
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General disorders
Fatigue
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8.8%
6/68 • Number of events 6
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Musculoskeletal and connective tissue disorders
Arthritis
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1.5%
1/68 • Number of events 1
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|
Musculoskeletal and connective tissue disorders
Back pain
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1.5%
1/68 • Number of events 1
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Psychiatric disorders
Libido decreased
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1.5%
1/68 • Number of events 1
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Renal and urinary disorders
Cystitis noninfective
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4.4%
3/68 • Number of events 3
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Renal and urinary disorders
Hematuria
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5.9%
4/68 • Number of events 4
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Renal and urinary disorders
Renal and urinary disorders - Other
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50.0%
34/68 • Number of events 82
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Renal and urinary disorders
Urinary frequency
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64.7%
44/68 • Number of events 62
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Renal and urinary disorders
Urinary incontinence
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13.2%
9/68 • Number of events 10
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Renal and urinary disorders
Urinary retention
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27.9%
19/68 • Number of events 27
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Renal and urinary disorders
Urinary tract pain
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11.8%
8/68 • Number of events 9
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|
Renal and urinary disorders
Urinary urgency
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50.0%
34/68 • Number of events 51
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Reproductive system and breast disorders
Erectile dysfunction
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2.9%
2/68 • Number of events 3
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Reproductive system and breast disorders
Genital edema
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1.5%
1/68 • Number of events 1
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Reproductive system and breast disorders
Perineal pain
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1.5%
1/68 • Number of events 1
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Reproductive system and breast disorders
Prostatic pain
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1.5%
1/68 • Number of events 1
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Reproductive system and breast disorders
Reproductive system and breast disorders - Other
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7.4%
5/68 • Number of events 5
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Reproductive system and breast disorders
Testicular pain
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2.9%
2/68 • Number of events 2
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Additional Information
Dr. Daniel Spratt, M.D.
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place