Trial Outcomes & Findings for Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation (NCT NCT01345539)
NCT ID: NCT01345539
Last Updated: 2023-10-11
Results Overview
Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Up to 3 Years (per patient)
Results posted on
2023-10-11
Participant Flow
Participant milestones
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radiosurgery for Patients With Oligometastatic Disease at Initial Presentation
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=24 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Age, Continuous
|
67.8333 years
STANDARD_DEVIATION 9.6534142 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
23 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 3 Years (per patient)Population: All treated patients able to be evaluated for toxicity grading.
Number of distinct patients with toxicities of Grade 3 or less per CTCAE v4.0
Outcome measures
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=2 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Acceptable Toxicity of SRS/SBRT
GASTROINTESTINAL DISORDERS - Constipation : Grade 2
|
1 participants
|
|
Acceptable Toxicity of SRS/SBRT
GASTROINTESTINAL DISORDERS - Constipation : Grade 3
|
0 participants
|
|
Acceptable Toxicity of SRS/SBRT
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Fatigue : Grade 2
|
1 participants
|
|
Acceptable Toxicity of SRS/SBRT
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - Fatigue : Grade 3
|
0 participants
|
|
Acceptable Toxicity of SRS/SBRT
METABOLISM AND NUTRITION DISORDERS - Anorexia : Grade 2
|
1 participants
|
|
Acceptable Toxicity of SRS/SBRT
METABOLISM AND NUTRITION DISORDERS - Anorexia : Grade 3
|
0 participants
|
|
Acceptable Toxicity of SRS/SBRT
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Flank pain : Grade 2
|
0 participants
|
|
Acceptable Toxicity of SRS/SBRT
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Flank pain : Grade 3
|
1 participants
|
|
Acceptable Toxicity of SRS/SBRT
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Neck pain : Grade 2
|
1 participants
|
|
Acceptable Toxicity of SRS/SBRT
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS - Neck pain : Grade 3
|
0 participants
|
|
Acceptable Toxicity of SRS/SBRT
VASCULAR DISORDERS - Hypertension : Grade 2
|
0 participants
|
|
Acceptable Toxicity of SRS/SBRT
VASCULAR DISORDERS - Hypertension : Grade 3
|
1 participants
|
PRIMARY outcome
Timeframe: Up to 3 years (per patient)Population: No data collected in the analysis population.
The presence of multiple metastatic disease sites (between 2 and 5 sites).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At pre-treatmentPopulation: Participants that completed both pre and post treatment patient outcomes assessments.
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of life Assessment is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical (PW), social (SW), emotional (EW), and functional (FW) well-being. Scoring: Five-point scale for each of the subscales is: 0 (not at all) to 4 (very much). PW has a Score range from 0-28. SW has a Score range from 0-28. EW has a Score range from 0-24. FW has a Score range from 0-28. Total overall score is thus from minimum of 0 to maximum of 108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=11 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
Physical Well-being
|
22.2727273 score on a scale
Standard Deviation 4.5186482
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
Social Well-being
|
25.4848485 score on a scale
Standard Deviation 3.7693386
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
Emotional Well-being
|
19.4545455 score on a scale
Standard Deviation 3.2051096
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
Functional Well-being
|
19.3636364 score on a scale
Standard Deviation 6.3130457
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Life Score
Total Well-being
|
86.5757273 score on a scale
Standard Deviation 14.4845869
|
SECONDARY outcome
Timeframe: At post-treatmentPopulation: Participants that completed both pre and post treatment patient outcomes assessments.
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of life Assessment is a patient self-administered 27-item questionnaire that measures health state in cancer patients in prior 7 days, including physical (PW), social (SW), emotional (EW), and functional (FW) well-being. Scoring: Five-point scale for each of the subscales is: 0 (not at all) to 4 (very much). PW has a Score range from 0-28. SW has a Score range from 0-28. EW has a Score range from 0-24. FW has a Score range from 0-28. Total overall score is thus from minimum of 0 to maximum of 108. Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=11 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
Physical Well-being
|
22.1282000 score on a scale
Standard Deviation 4.5186482
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
Social Well-being
|
24.0035692 score on a scale
Standard Deviation 3.0955351
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
Emotional Well-being
|
19.6250000 score on a scale
Standard Deviation 4.3951633
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
Functional Well-being
|
18.0651094 score on a scale
Standard Deviation 7.0332731
|
|
The Functional Assessment of Cancer Therapy - General (FACT-G) Quality of Score
Total Well-being
|
83.7614375 score on a scale
Standard Deviation 15.2425018
|
SECONDARY outcome
Timeframe: Up to 5 years (per patient)Population: No data collected in the analysis population
Proportion of patients with local Complete Response (CR), Partial Response (PR) or Stable Disease (SD) after trial therapy as measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at sites of metastatic disease. Per RECIST: (CR): Disappearance of all target lesions; (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: No data collected in the analysis population.
Proportion of patients with local Complete Response (CR), Partial Response (PR) or Stable Disease (SD) after trial therapy as measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at primary disease sites. Per RECIST: (CR): Disappearance of all target lesions; (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years (per patient)Population: Patients that received study treatment and were radiologically evaluated for confirmed disease progression.
The number of patients that experience oligometastatic disease progression/recurrence after treatment for their primary disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at primary disease sites. Per RECIST, Progressive Disease (PD) includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=23 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Analysis of Patterns of Failure Post-SRS/SBRT
|
18 Participants
|
SECONDARY outcome
Timeframe: At 2 years (cohort)Population: Participants that received study treatment.
Percentage of participants alive at 2 years post start of treatment.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=21 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Two-year Overall Survival
|
57.14 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 years (cohort)Population: Participants that received study treatment.
Mean number of months patients remain alive from the day of trial enrollment until either an death from any cause or last follow-up.
Outcome measures
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=21 Participants
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Overall Survival (OS)
|
32.7667 months
Standard Error 5.1554
|
Adverse Events
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=24 participants at risk
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Cardiac disorders
Cardiac Arrest
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
Other adverse events
| Measure |
Stereotactic Body Radiotherapy (SBRT) With/Without Chemotherapy
n=24 participants at risk
Sequence of therapy: SRS/SBRT will be used for all sites of metastatic disease in close approximation to initiation of treatment for the primary disease site (within 6 weeks). Ideally, SRS/SBRT would occur first followed by treatment to primary site. However, in some circumstances surgical resection of the primary site could precede SRS/SBRT, especially if surgical resection is required for pathological confirmation of disease.
Chemotherapy choice of agents is at the discretion of the treating medical oncologist; chemotherapy may be initiated after stereotactic radiosurgery treatment of the primary disease site has been completed.
Stereotactic Radiosurgery (SRS): Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Patients may have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met.
Chemotherapy: Chemotherapy choice of agents is at the discretion of the treating medical oncologist.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Cardiac disorders
Coronary artery disease
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
General disorders
Fatigue
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
General disorders
Diabetes
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Investigations
Hyperlipidemia
|
8.3%
2/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Psychiatric disorders
Depression
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
|
Vascular disorders
Hypertension
|
4.2%
1/24 • Adverse Events data were collected for up to 3 years per patient, and up to 9 years for the study population.
Adverse Events were defined using National Cancer Institute (NCI) CTCAE version 4
|
Additional Information
Barbara M. Stadterman, MPH, MSCR
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