Trial Outcomes & Findings for A Study For Using Radiosurgery On Limited Metastases (NCT NCT00178399)

Results Overview

Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

128 participants

Primary outcome timeframe

24 months

Results posted on

2018-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiation Therapy Stereotactic Body Radiation Therapy
Overall Study STARTED	128
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Stereotactic Body Radiation Therapy Stereotactic Body Radiation Therapy
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	8
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study For Using Radiosurgery On Limited Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Body Radiation Therapy n=128 Participants Stereotactic Body Radiation Therapy
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants
Region of Enrollment United States	128 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Only curative patients were included in this analysis

Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy n=30 Participants Subjects received Stereotactic Body Radiation Therapy
Percentage of Curatively Treated Patients With Progression-free Survival	16 percentage of participants

PRIMARY outcome

Timeframe: 24 months

Population: Only palliative patients were included in this analysis

Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy n=19 Participants Subjects received Stereotactic Body Radiation Therapy
Percentage of Palliatively Treated Patients With Progression-free Survival	38 percentage of participants

SECONDARY outcome

Timeframe: 30 months from date of registration.

Population: No data was collected for this outcome measure.

Correlation of data from QOL questionnaires and blood markers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years

Population: No data was collected for this outcome measure.

Analysis or response and progression.

Outcome measures

Outcome data not reported

Adverse Events

Stereotactic Body Radiation Therapy

Serious events: 0 serious events

Other events: 24 other events

Deaths: 123 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stereotactic Body Radiation Therapy n=128 participants at risk Stereotactic Body Radiation Therapy
Respiratory, thoracic and mediastinal disorders Pneumonitis/Pulmonary Infiltrates	15.6% 20/128
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.78% 1/128
Gastrointestinal disorders Esophagitis	1.6% 2/128
Respiratory, thoracic and mediastinal disorders Pericardial effusion	0.78% 1/128

Additional Information

Michael Milano

University of Rochester

Phone: 585-273-4096

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place