Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer (NCT NCT01657617)
NCT ID: NCT01657617
Last Updated: 2018-10-05
Results Overview
Pneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2018-10-05
Participant Flow
Participants were recruited in the oncology clinics at the University of Kentucky between 2007 and 2014
Participant milestones
| Measure |
Radiation Therapy
Boost Stereotactic Body Radiation Therapy
Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Radiation Therapy
n=35 Participants
Boost Stereotactic Body Radiation Therapy
Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
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|---|---|
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Age, Continuous
|
63 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.
Outcome measures
| Measure |
Radiation Therapy
n=35 Participants
Boost Stereotactic Body Radiation Therapy
Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
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|---|---|
|
Boost Dose Toxicity
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe response rates of the residual primary tumor following SBRT boost will be determined using a modified version of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Data will be presented as the percent of participants with recurrence of the primary tumor after extended follow up, up to 5 years.
Outcome measures
| Measure |
Radiation Therapy
n=35 Participants
Boost Stereotactic Body Radiation Therapy
Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
|
|---|---|
|
Primary Tumor Relapse Following SBRT
|
8 Participants
|
Adverse Events
Radiation Therapy
Serious events: 2 serious events
Other events: 0 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Radiation Therapy
n=35 participants at risk
Boost Stereotactic Body Radiation Therapy
Boost Stereotactic Body Radiation Therapy: The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Fatal hemoptysis
|
5.7%
2/35 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place