Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751747
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2020-12-23
Brief Title:
Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
The Role of Adaptive Radiation Planning in Patients With Non-Small Cell Lung Cancer on Radiation Induced Toxicity
Status:
RECRUITING
Status Verified Date:
2023-12
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 phase II trial studies the effect of adaptive radiation planning in reducing side effects associated with radiation treatment and immunotherapy in patients with stage II-IV non-small cell lung cancer Prior to radiation patients undergo simulation where they are positioned on the treatment table in a manner that can be reproduced each time they receive treatment in order to reach the tumor exactly at the same spot each time However a patients tumor may shrink as they receive radiation exposing healthy tissue to radiation as well Adaptive radiation planning involves re-designing a treatment plan at set intervals The purpose of this study is to see whether establishing set time points through adaptive radiation planning regardless of whether the doctor notices a significant decrease in tumor size will reduce some of the side effects associated with radiation treatment and immunotherapy
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue with the intention of establishing a new standard treatment modality
OUTLINE
Patients undergo computed tomography CT stimulation with or without intravenous IV contrast over 15 hours on days -15 to -1 then undergo standard of care SOC chemoradiation on days 1-40 Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29
After completion of study patients are followed up at 3-12 weeks and then every 6 months for approximately 2 years
I To evaluate whether implementing set intervals for radiation replanning reduces cardiopulmonary toxicity and preserves healthy lung and heart tissue with the intention of establishing a new standard treatment modality
OUTLINE
Patients undergo computed tomography CT stimulation with or without intravenous IV contrast over 15 hours on days -15 to -1 then undergo standard of care SOC chemoradiation on days 1-40 Patients also undergo additional CT scan simulations without IV contrast over 20 minutes each on days 15 and 29
After completion of study patients are followed up at 3-12 weeks and then every 6 months for approximately 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-08292 | REGISTRY | None | None |
| Pro2020002153 | None | None | None |
| 032009 | OTHER | None | None |
| P30CA072720 | NIH | Rutgers Cancer Institute of New Jersey | httpsreporternihgovquickSearchP30CA072720 |