Trial Outcomes & Findings for Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver (NCT NCT01030757)
NCT ID: NCT01030757
Last Updated: 2015-07-07
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
1 year
Results posted on
2015-07-07
Participant Flow
8 subjects were screened; 6 did not meet entry criteria. 2 subjects were enrolled
Participant milestones
| Measure |
Tomotherapy
Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
* Dose will be prescribed to the isodose line which covers at least 90% of the PTV
* Dose homogeneity +/- 5%
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Metastatic Tumors to the Liver
Baseline characteristics by cohort
| Measure |
Tomotherapy
n=2 Participants
Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.
Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days
* Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours
* Dose will be prescribed to the isodose line which covers at least 90% of the PTV
* Dose homogeneity +/- 5%
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Study was terminated due to low accrual; no results to report
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Study was terminated due to low accrual; no results to report.
Outcome measures
Outcome data not reported
Adverse Events
Tomotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place