Trial Outcomes & Findings for Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (NCT NCT03623334)
NCT ID: NCT03623334
Last Updated: 2021-05-04
Results Overview
A dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment\*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
90 days after start of treatment up to 1 year
Results posted on
2021-05-04
Participant Flow
Participant milestones
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (Total 50 Gy)
Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks
Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy.
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (Total 55-Gy )
Image-guided radiation therapy (IGRT) which is given over the course of about 3 weeks
Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy.
|
Dose Level C: IGRT 4Gy x 15 Fractions ( Total 60Gy)
4 Gy per fraction for a total dose of 60 Gy will be tested. Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks
Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
21
|
19
|
|
Overall Study
COMPLETED
|
15
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy
Baseline characteristics by cohort
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (Total 50Gy)
n=15 Participants
Image-guided radiation therapy (IGRT) does of 3.33Gy for 15 fractions (total dose = 50 Gy) which is given over the course of about 3 weeks
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (Total 55Gy)
n=21 Participants
Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 55 Gy) which is given over the course of about 3 weeks
|
Dose Level C: IGRT 4Gy x 15 Fractions ( Total 60Gy)
n=19 Participants
4 Gy per fraction for a total dose of 60 Gy will be tested. Image-guided radiation therapy (IGRT) dose which is given over the course of about 3 weeks
Patients with stage II to IV or recurrent NSCLC and Eastern Cooperative Oncology Group performance status of 2 or greater and not candidates for surgical resection, stereotactic radiation, or concurrent chemoradiation were eligible. Highly conformal radiation therapy was given to treat intrathoracic disease in 15 fractions to a total of 50, 55, or 60 Gy.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
65 years
n=7 Participants
|
65 years
n=5 Participants
|
65 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 days after start of treatment up to 1 yearA dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment\*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests)
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=15 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=21 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=19 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included
Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=9 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=17 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=15 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Local Regional Tumor Control at 3 Months
|
4 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included
Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=8 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=9 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=10 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Local Regional Tumor Control at 6 Months
|
2 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included
Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=3 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=5 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=7 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Local Regional Tumor Control at 9 Months
|
2 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included
Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=1 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=3 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=5 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Local Regional Tumor Control at 12 Months
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 16 monthsPopulation: Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included
Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=1 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=1 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=3 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Local Regional Tumor Control at 16 Months
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 20 monthsPopulation: Only convenient sample were included. Those who died, lost to follow-up, refused scans were not included
Local control is defined as the absence of isolated progression (stable disease or responsive disease at last follow-up) within the primary tumor. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=1 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=1 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Number of Participants With Local Regional Tumor Control at 20 Months
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOverall survival is defined as participants alive during the research period.
Outcome measures
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=15 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.33 Gy per fraction for 15 fractions (total dose = 50 Gy).
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=21 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 3.67 Gy per fraction for 15 fractions (total dose = 55 Gy).
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy)
n=19 Participants
In this cohort, the starting dose of Image-Guided Radiation Therapy (IGRT) will be 4.00 Gy per fraction for 15 fractions (total dose = 60 Gy).
|
|---|---|---|---|
|
Overall Survival at 6 Months
|
11 Participants
|
13 Participants
|
12 Participants
|
Adverse Events
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 14 deaths
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
Serious events: 4 serious events
Other events: 20 other events
Deaths: 14 deaths
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy
Serious events: 4 serious events
Other events: 18 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=15 participants at risk
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=21 participants at risk
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy
n=19 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
G2 or higher dyspnea
|
33.3%
5/15 • This was collected over a period of 12 months.
|
19.0%
4/21 • This was collected over a period of 12 months.
|
21.1%
4/19 • This was collected over a period of 12 months.
|
|
General disorders
G2 or higher Esophagitis
|
0.00%
0/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
Other adverse events
| Measure |
Dose Level A: IGRT 3.33Gy x 15 Fractions (50 Gy)
n=15 participants at risk
|
Dose Level B: IGRT 3.67Gy x 15 Fractions (55 Gy)
n=21 participants at risk
|
Dose Level C: IGRT 4.00Gy x 15 Fractions (60 Gy
n=19 participants at risk
|
|---|---|---|---|
|
General disorders
≤G2 Esophagitis
|
100.0%
15/15 • This was collected over a period of 12 months.
|
95.2%
20/21 • This was collected over a period of 12 months.
|
94.7%
18/19 • This was collected over a period of 12 months.
|
|
Cardiac disorders
≤G2 Dyspnea
|
66.7%
10/15 • This was collected over a period of 12 months.
|
81.0%
17/21 • This was collected over a period of 12 months.
|
78.9%
15/19 • This was collected over a period of 12 months.
|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • This was collected over a period of 12 months.
|
9.5%
2/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Psychiatric disorders
Anorexia
|
20.0%
3/15 • This was collected over a period of 12 months.
|
9.5%
2/21 • This was collected over a period of 12 months.
|
21.1%
4/19 • This was collected over a period of 12 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.0%
3/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
10.5%
2/19 • This was collected over a period of 12 months.
|
|
General disorders
Dysphagia
|
20.0%
3/15 • This was collected over a period of 12 months.
|
9.5%
2/21 • This was collected over a period of 12 months.
|
10.5%
2/19 • This was collected over a period of 12 months.
|
|
Nervous system disorders
Pain
|
20.0%
3/15 • This was collected over a period of 12 months.
|
38.1%
8/21 • This was collected over a period of 12 months.
|
63.2%
12/19 • This was collected over a period of 12 months.
|
|
Nervous system disorders
Anxiety
|
6.7%
1/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/15 • This was collected over a period of 12 months.
|
9.5%
2/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
21.1%
4/19 • This was collected over a period of 12 months.
|
|
Nervous system disorders
Confusion
|
0.00%
0/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • This was collected over a period of 12 months.
|
9.5%
2/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Psychiatric disorders
Delirium
|
6.7%
1/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dysarthria
|
6.7%
1/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
53.3%
8/15 • This was collected over a period of 12 months.
|
42.9%
9/21 • This was collected over a period of 12 months.
|
36.8%
7/19 • This was collected over a period of 12 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.7%
1/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15 • This was collected over a period of 12 months.
|
14.3%
3/21 • This was collected over a period of 12 months.
|
21.1%
4/19 • This was collected over a period of 12 months.
|
|
Musculoskeletal and connective tissue disorders
Neuropathy
|
6.7%
1/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • This was collected over a period of 12 months.
|
9.5%
2/21 • This was collected over a period of 12 months.
|
10.5%
2/19 • This was collected over a period of 12 months.
|
|
Infections and infestations
Pneumonia
|
26.7%
4/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
6.7%
1/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
5.3%
1/19 • This was collected over a period of 12 months.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/15 • This was collected over a period of 12 months.
|
4.8%
1/21 • This was collected over a period of 12 months.
|
0.00%
0/19 • This was collected over a period of 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/15 • This was collected over a period of 12 months.
|
0.00%
0/21 • This was collected over a period of 12 months.
|
10.5%
2/19 • This was collected over a period of 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place