Trial Outcomes & Findings for Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain (NCT NCT00550654)
NCT ID: NCT00550654
Last Updated: 2017-01-13
Results Overview
Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.
TERMINATED
PHASE2
1 participants
6 months
2017-01-13
Participant Flow
Participant milestones
| Measure |
Radiation Therapy in Metastatic Cancer
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain
Baseline characteristics by cohort
| Measure |
Radiation Therapy in Metastatic Cancer
n=1 Participants
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION NA • n=93 Participants
|
|
Gender
Female
|
0 Participants
n=93 Participants
|
|
Gender
Male
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: No data/specimens were collected. Study was terminated due to poor accrual.
Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 months, 11 daysHere is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Radiation Therapy in Metastatic Cancer
n=1 Participants
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
|
|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
SECONDARY outcome
Timeframe: 6-12 monthsPopulation: No data/specimens were collected. Study was terminated due to poor accrual.
Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: No data/specimens were collected. Study was terminated due to poor accrual.
Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a \>/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression. Progression is an interval increase in the maximal dimension of the target lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One to three months of followupPopulation: No data/specimens were collected. Study was terminated due to poor accrual.
Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One and three months of follow upPopulation: No data/specimens were collected. Study was terminated due to poor accrual.
Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and prior to termination of systemic therapy or protocol withdrawalPopulation: No data/specimens were collected. Study was terminated due to poor accrual.
Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.
Outcome measures
Outcome data not reported
Adverse Events
Radiation Therapy in Metastatic Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radiation Therapy in Metastatic Cancer
n=1 participants at risk
Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain::Buttock
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
100.0%
1/1 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Weight loss
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify)
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
100.0%
1/1 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
100.0%
1/1 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
100.0%
1/1 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: Nose
|
100.0%
1/1 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
100.0%
1/1 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1
|
Additional Information
Deborah Citrin, M.D.
National Cancer Institute, National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place