Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01586104
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2012-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases
Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Organization:
Study Overview
Official Title:
Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Detailed Description:
OBJECTIVES:
I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional setting with central quality control for children and young adults with metastatic tumors in the lungs.
II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation by comparing treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this study.
III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT at a minimum period of six months after IMRT.
OUTLINE:
Patients undergo cardiac-sparing whole lung IMRT.
After completion of study treatment, patients are followed up for 1-5 years.
I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional setting with central quality control for children and young adults with metastatic tumors in the lungs.
II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation by comparing treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this study.
III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT at a minimum period of six months after IMRT.
OUTLINE:
Patients undergo cardiac-sparing whole lung IMRT.
After completion of study treatment, patients are followed up for 1-5 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21CA159547 | NIH | None | https://reporter.nih.gov/quic… | View |