Trial Outcomes & Findings for Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer (NCT NCT01656460)

NCT ID: NCT01656460

Last Updated: 2020-07-22

Results Overview

Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2020-07-22

Participant Flow

Participant milestones

Participant milestones
Measure
Stereotactic Radiation Dose Level 1
Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Stereotactic Radiation Dose Level 2
Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Stereotactic Radiation Dose Level 3
Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Stereotactic Radiation Dose Level 4
Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Overall Study
STARTED
3
3
3
3
Overall Study
COMPLETED
3
3
3
3
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Stereotactic Radiation
n=12 Participants
stereotactic
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
5 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
Age, Continuous
63.9 years
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT.

Outcome measures

Outcome measures
Measure
Arm 1-Stereotactic Radiation Dose Level 1
n=3 Participants
Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Arm 2-Stereotactic Radiation Dose Level 2
n=3 Participants
Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Arm 3-Stereotactic Radiation Dose Level 3
n=3 Participants
Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Arm 4-Stereotactic Radiation Dose Level 4
n=3 Participants
Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Early and Intermediate Toxicity for Dose Limiting Toxicity
0 participants
0 participants
0 participants
0 participants

Adverse Events

Arm 1-Stereotactic Radiation Dose Level 1

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Arm 2-Stereotactic Radiation Dose Level 2

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Arm 3-Stereotactic Radiation Dose Level 3

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Arm 4-Stereotactic Radiation Dose Level 4

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1-Stereotactic Radiation Dose Level 1
n=3 participants at risk
Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Arm 2-Stereotactic Radiation Dose Level 2
n=3 participants at risk
Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Arm 3-Stereotactic Radiation Dose Level 3
n=3 participants at risk
Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Arm 4-Stereotactic Radiation Dose Level 4
n=3 participants at risk
Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Investigations
K(3), AKI secondary to cisplatin nephrotoxicity(5)
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
AKI(2*) RT poor intake, CR(2*) RT poor intake, Fatigue (2*) RT pneumonia or chemo, H/A(2*) related
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
hypoglycemia(2*), chest pain (3*), Hyperglycemia(3*), HGB(2*), CR(1*) k(1*)
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Dyspnea 4*, Tachycardia 2*, Fever 1*cough 1*-
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Bronchopulmonary Hemorrhage (5)
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
upper respiratory infection
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
URI (3*) rt chemo, PLT(2*) PR chemo, hyponatremia (3*) PR chemo, bilateral thigh pain(2*) suspected
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT

Other adverse events

Other adverse events
Measure
Arm 1-Stereotactic Radiation Dose Level 1
n=3 participants at risk
Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy
Arm 2-Stereotactic Radiation Dose Level 2
n=3 participants at risk
Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
Arm 3-Stereotactic Radiation Dose Level 3
n=3 participants at risk
Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
Arm 4-Stereotactic Radiation Dose Level 4
n=3 participants at risk
Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
Investigations
HgB
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
66.7%
2/3 • Number of events 2 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
vomiting
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Creatinine
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
WBC
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
66.7%
2/3 • Number of events 2 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Thrombocytopenia
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
dermatitis
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
pleural effusion
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Lymph
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
66.7%
2/3 • Number of events 2 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
100.0%
3/3 • Number of events 3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Bili
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
dyspnea/hypoxia
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
myalgia
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
esophagitis
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
K
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
ANC
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
cough
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
66.7%
2/3 • Number of events 2 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
fatigue
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
pain- thigh/leg/groin/chest wall
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
nausea
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Ca
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
pneumonitis ,upper respiratory infection (URI),lung Infection (influenza A)
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
AST
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
66.7%
2/3 • Number of events 2 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
ALT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
Magnesium
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
fever
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
diarrhea
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
chills
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
edema
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Investigations
aspiration
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
0.00%
0/3 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
33.3%
1/3 • Number of events 1 • Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT

Additional Information

Thomas DiPetrillo, MD

Brown University Oncology Research Group (BrUOG)

Phone: 4018633000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place