Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008730
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2023-07-31
Brief Title:
Proton Beam Radiation Therapy After Treatment for Resected N2 Non-Small Cell Lung Cancer
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Proton Beam Radiation Therapy in Patients With Resected N2 Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 clinical trial tests proton beam radiation therapy in patients with non-small cell lung cancer who have undergone surgical resection and have lymph nodes involving the middle of the chest Proton therapy is a type of radiation treatment that kills cancer cells while avoiding surrounding healthy tissue Proton beam therapy is sometimes used after cancer surgery to reduce the risk of cancer recurrence coming back Giving proton beam radiation therapy may work better than conventional radiation treatment after surgery in patients with non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To assess the safety of proton beam radiation therapy PBRT for resected N2 non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints
II To assess the efficacy of PBRT for resected N2 NSCLC
OUTLINE
Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study Patients also undergo collection of blood samples
Patients are followed up for 24 months after first dose of radiotherapy
I To assess the safety of proton beam radiation therapy PBRT for resected N2 non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints
II To assess the efficacy of PBRT for resected N2 NSCLC
OUTLINE
Patients undergo radiation treatment planning and then undergo proton beam radiation therapy on study Patients also undergo collection of blood samples
Patients are followed up for 24 months after first dose of radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
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-2023-02941 | REGISTRY | None | None |
| STUDY00005105 | OTHER | None | None |
| RAD5621-22 | OTHER | None | None |
| P30CA138292 | NIH | Emory University HospitalWinship Cancer Institute | httpsreporternihgovquickSearchP30CA138292 |