Trial Outcomes & Findings for Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung (NCT NCT00832780)

Last Updated: 2021-05-21

Results Overview

RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

2 years

Results posted on

2021-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiation (SBRT) 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Overall Study STARTED	44
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Stereotactic Body Radiation (SBRT) 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Overall Study Death	16
Overall Study Lost to Follow-up	4
Overall Study no reason given	2
Overall Study other complicating condition	2
Overall Study Physician Decision	1

Baseline Characteristics

Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	60 Gy Using 12 Gy Per Fraction Over 5 Fractions n=44 Participants Radiation dose of 60 Gy administered in 5 fractions of 12 Gy each.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants
Age, Continuous	68.42 years STANDARD_DEVIATION 9.98 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	40 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
Region of Enrollment United States	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation (SBRT) n=50 tumors 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Response Rate (RR):	38 tumors

SECONDARY outcome

Timeframe: 2 years

Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation (SBRT) n=44 Participants 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Treatment Related Toxicity cough	4 participants
Treatment Related Toxicity fatigue	1 participants
Treatment Related Toxicity chest wall pain	7 participants
Treatment Related Toxicity shortness of breath	3 participants
Treatment Related Toxicity wheeze	1 participants

SECONDARY outcome

Timeframe: up to 67 months

The time from treatment initiation to death by any cause

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation (SBRT) n=44 Participants 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Overall Survival (OS)	44 months Interval 24.0 to 67.0

SECONDARY outcome

Timeframe: 2 years

The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation (SBRT) n=44 Participants 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Progression Free Survival (PFS)	31 Participants

SECONDARY outcome

Timeframe: 2 years

CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): \>= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation (SBRT) n=50 tumors 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Clinical Benefit Rate (CBR)	41 tumors

Adverse Events

Stereotactic Body Radiation (SBRT)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Stereotactic Body Radiation (SBRT) n=44 participants at risk 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: 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 planning target volume. Dose homogeneity +/- 5%.
Psychiatric disorders Agitation	2.3% 1/44 • Number of events 1 • 6 years, 9 months
Cardiac disorders Chest pain	15.9% 7/44 • Number of events 7 • 6 years, 9 months
Respiratory, thoracic and mediastinal disorders Dyspnea	6.8% 3/44 • Number of events 3 • 6 years, 9 months
General disorders Fatigue	6.8% 3/44 • Number of events 3 • 6 years, 9 months
General disorders Fever	2.3% 1/44 • Number of events 1 • 6 years, 9 months
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.3% 1/44 • Number of events 1 • 6 years, 9 months
Musculoskeletal and connective tissue disorders Myalgia	2.3% 1/44 • Number of events 1 • 6 years, 9 months
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 1/44 • Number of events 1 • 6 years, 9 months
Respiratory, thoracic and mediastinal disorders cough	9.1% 4/44 • Number of events 4 • 6 years, 9 months
Respiratory, thoracic and mediastinal disorders wheeze	2.3% 1/44 • Number of events 1 • 6 years, 9 months

Additional Information

Ben Liem, MD

University of New Mexico Comprehensive Cancer Center

Phone: 505-272-0086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place