Trial Outcomes & Findings for Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases (NCT NCT01586104)
NCT ID: NCT01586104
Last Updated: 2025-02-10
Results Overview
Feasibility is defined as an enrolled patient receiving the IMRT treatment as stipulated in the protocol. Feasibility of delivering whole lung IMRT will be demonstrated by obtaining central (Quality Assurance Review Center 'QARC') quality control approval of enrolled patient treatment plans according to the protocol guidelines for the 20 subjects enrolled onto the study. If an enrolled patient did not receive the IMRT treatment as stipulated in the protocol this subject then the treatment will be considered not feasible in this patient.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
All IMRT treatment plans were centrally reviewed within 1-2 days of receipt of the radiation therapy plan. The feasibility was determined as 'feasible' if deemed in accordance with protocol guidelines after central QARC review within 1-2 days of receipt.
Results posted on
2025-02-10
Participant Flow
Participant milestones
| Measure |
Treatment (IMRT)
Patients undergo cardiac-sparing whole lung IMRT.
intensity-modulated radiation therapy: Undergo cardiac-sparing whole lung IMRT
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
Baseline characteristics by cohort
| Measure |
Treatment (IMRT)
n=20 Participants
Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
intensity-modulated radiation therapy: Undergo cardiac-sparing whole lung IMRT
|
|---|---|
|
Age, Continuous
|
13 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: All IMRT treatment plans were centrally reviewed within 1-2 days of receipt of the radiation therapy plan. The feasibility was determined as 'feasible' if deemed in accordance with protocol guidelines after central QARC review within 1-2 days of receipt.Population: 14 patients had pediatric sarcomas; 5 had Wilms tumor; 1 had hepatoblastoma. 15/20 received RT to primary site. 15 had CS-IMRT as part of primary therapy vs 5 had CS-IMRT at relapse/progressive disease. At time of CS-IMRT, 18/20 patients' lung tumors were in remission/stable \& 2 had progressive disease.
Feasibility is defined as an enrolled patient receiving the IMRT treatment as stipulated in the protocol. Feasibility of delivering whole lung IMRT will be demonstrated by obtaining central (Quality Assurance Review Center 'QARC') quality control approval of enrolled patient treatment plans according to the protocol guidelines for the 20 subjects enrolled onto the study. If an enrolled patient did not receive the IMRT treatment as stipulated in the protocol this subject then the treatment will be considered not feasible in this patient.
Outcome measures
| Measure |
Treatment (IMRT)
n=20 Participants
Patients had radiation therapy planning performed for cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT) according to stipulated guidelines in the protocol.
|
|---|---|
|
Feasibility of Delivering Cardiac-sparing IMRT With Central Quality Control in 20 Subjects
|
20 Participants
|
PRIMARY outcome
Timeframe: From date of enrollment until the date of first documented progression, relapse or date of death from any cause up to an average of 3 years.Population: Overall survival and incidence rates of additional relevant clinical data
Serial CT scans of the chest were examined to determine lung-metastasis free survival
Outcome measures
| Measure |
Treatment (IMRT)
n=20 Participants
Patients had radiation therapy planning performed for cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT) according to stipulated guidelines in the protocol.
|
|---|---|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
2yr overall survival
|
18 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
3yr overall survival
|
18 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
2yr lung-metastasis progression free survival
|
13 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
3yr lung-metastasis progression free survival
|
10 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
Pulmonary relapse
|
8 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
Pulmonary relapse - after primary therapy
|
4 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
Pulmonary relapse - after relapse/progression
|
4 Participants
|
|
Short-term Efficacy (Lung-metastases Free Survival, Overall Survival, Pulmonary Relapse, Deceased From Progressive Disease)
Deceased from progressive disease
|
2 Participants
|
SECONDARY outcome
Timeframe: This outcome is measured from central review of radiation plans within 1-2 days of receipt.The IMRT and standard anteroposterior (AP-PA) treatment plans were reviewed and compared for target coverage and organ dose-volume histograms. The mean percentage volume of the organ or organ sub-region receiving a percentage of the dose was estimated from the computerized treatment plans for these two techniques were estimated and compared statistically
Outcome measures
| Measure |
Treatment (IMRT)
n=20 Participants
Patients had radiation therapy planning performed for cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT) according to stipulated guidelines in the protocol.
|
|---|---|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Ventricle - V95 (%) for IMRT
|
18 Mean % radiation dose to % organ volume
Standard Deviation 8.9
|
|
Mean Percentage Radiation Dose to Organ Volumes
Liver - V50 (%) for AP-PA
|
54 Mean % radiation dose to % organ volume
Standard Deviation 11.4
|
|
Mean Percentage Radiation Dose to Organ Volumes
Heart - V50 (%) for IMRT
|
96 Mean % radiation dose to % organ volume
Standard Deviation 5.4
|
|
Mean Percentage Radiation Dose to Organ Volumes
Heart - V50 (%) for AP- PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 0.8
|
|
Mean Percentage Radiation Dose to Organ Volumes
Heart - V83 (%) for IMRT
|
65 Mean % radiation dose to % organ volume
Standard Deviation 12.1
|
|
Mean Percentage Radiation Dose to Organ Volumes
Heart - V83 (%) for AP-PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 2.2
|
|
Mean Percentage Radiation Dose to Organ Volumes
Heart - V95 (%) for IMRT
|
39 Mean % radiation dose to % organ volume
Standard Deviation 15.5
|
|
Mean Percentage Radiation Dose to Organ Volumes
Heart- V95 (%) for AP-PA
|
97 Mean % radiation dose to % organ volume
Standard Deviation 6.7
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Ventricle - V50 (%) for IMRT
|
95 Mean % radiation dose to % organ volume
Standard Deviation 7.8
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Ventricle - V50 (%) for AP-PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 0
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Ventricle - V95 (%) for IMRT
|
33 Mean % radiation dose to % organ volume
Standard Deviation 15.9
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Ventricle - V95 (%) for AP-PA
|
99 Mean % radiation dose to % organ volume
Standard Deviation 2.7
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Ventricle - V50 (%) for IMRT
|
91 Mean % radiation dose to % organ volume
Standard Deviation 9.8
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Ventricle - V50 (%) for AP-PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 1.6
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Ventricle - V83 (%) for IMRT
|
42 Mean % radiation dose to % organ volume
Standard Deviation 12.7
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Ventricle - V83 (%) for AP-PA
|
99 Mean % radiation dose to % organ volume
Standard Deviation 4
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Ventricle - V95 (%) for AP-PA
|
97 Mean % radiation dose to % organ volume
Standard Deviation 8.2
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Atrium - V50 (%) for IMRT
|
99 Mean % radiation dose to % organ volume
Standard Deviation 0.4
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Atrium - V50 (%) for AP-PA
|
99 Mean % radiation dose to % organ volume
Standard Deviation 0.7
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Atrium - V95 (%) for IMRT
|
57 Mean % radiation dose to % organ volume
Standard Deviation 22.5
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Atrium - V95 (%) for AP-PA
|
97 Mean % radiation dose to % organ volume
Standard Deviation 11.1
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Atrium V50 (%) for IMRT
|
99 Mean % radiation dose to % organ volume
Standard Deviation 0.4
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Atrium V50 (%) for AP-PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 0.2
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Atrium - V95 (%) for IMRT
|
55 Mean % radiation dose to % organ volume
Standard Deviation 22.3
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Atrium - V95 (%) for AP-PA
|
94 Mean % radiation dose to % organ volume
Standard Deviation 15.4
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Coronary Artery - V95 (%) for IMRT
|
100 Mean % radiation dose to % organ volume
Standard Deviation 0
|
|
Mean Percentage Radiation Dose to Organ Volumes
Right Coronary Artery - V95 (%) for AP-PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 0
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Coronary Artery - V95 (%) for IMRT
|
88 Mean % radiation dose to % organ volume
Standard Deviation 9.9
|
|
Mean Percentage Radiation Dose to Organ Volumes
Left Coronary Artery - V95 (%) for AP-PA
|
99 Mean % radiation dose to % organ volume
Standard Deviation 1.3
|
|
Mean Percentage Radiation Dose to Organ Volumes
Myocardium - V50 (%) for IMRT
|
94 Mean % radiation dose to % organ volume
Standard Deviation 8
|
|
Mean Percentage Radiation Dose to Organ Volumes
Myocardium - V50 (%) for AP-PA
|
100 Mean % radiation dose to % organ volume
Standard Deviation 0
|
|
Mean Percentage Radiation Dose to Organ Volumes
Myocardium - V95 (%) for IMRT
|
69 Mean % radiation dose to % organ volume
Standard Deviation 7.56
|
|
Mean Percentage Radiation Dose to Organ Volumes
Myocardium - V95 (%) for AP-PA
|
99 Mean % radiation dose to % organ volume
Standard Deviation 0.88
|
|
Mean Percentage Radiation Dose to Organ Volumes
Thyroid - V50 (%) for IMRT
|
44 Mean % radiation dose to % organ volume
Standard Deviation 32.5
|
|
Mean Percentage Radiation Dose to Organ Volumes
Thyroid - V50 (%) for AP-PA
|
33 Mean % radiation dose to % organ volume
Standard Deviation 31.3
|
|
Mean Percentage Radiation Dose to Organ Volumes
Kidneys - V50 (%) for IMRT
|
5 Mean % radiation dose to % organ volume
Standard Deviation 7.6
|
|
Mean Percentage Radiation Dose to Organ Volumes
Kidneys - V50 (%) for AP-PA
|
6 Mean % radiation dose to % organ volume
Standard Deviation 6.8
|
|
Mean Percentage Radiation Dose to Organ Volumes
Stomach - V50 (%) for IMRT
|
62 Mean % radiation dose to % organ volume
Standard Deviation 21.7
|
|
Mean Percentage Radiation Dose to Organ Volumes
Stomach - V50 (%) for AP-PA
|
62 Mean % radiation dose to % organ volume
Standard Deviation 24.5
|
|
Mean Percentage Radiation Dose to Organ Volumes
Liver - V50 (%) for IMRT
|
55 Mean % radiation dose to % organ volume
Standard Deviation 11.4
|
Adverse Events
Treatment (IMRT)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (IMRT)
n=20 participants at risk
Patients undergo cardiac-sparing whole lung intensity-modulated radiation therapy (IMRT).
|
|---|---|
|
General disorders
Deceased from progressive disease.
|
10.0%
2/20 • Number of events 2
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Walterhouse
Ann & Robert H. Lurie Children's Hospital of Chicago
Phone: 3122274000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place