Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205927
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-12-17
Brief Title:
Randomized Study of Carbon Ion Boost in Hypoxic Lesions for Locally Advanced Non-small Cell Lung Cancer
Sponsor:
Jian Chen
Organization:
Shanghai Proton and Heavy Ion Center
Study Overview
Official Title:
Randomized Study of Carbon Ion Boost in Hypoxic Lesions Identified by 18F-Misonidazole PETCT in Patients With Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-01
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:
The goal of this randomized clinical trial is to learn about if carbon ion radiotherapy dose boost in hypoxia lesions detected by 18F-Misonidazole PETCT could improve clinical outcomes in locally advanced non-small cell lung cancer patients compared with standard treatment protocol in our center The patients will be randomly divided into two arms standard treatment arm and hypoxic lesions dose boost arm The standard treatment arm will receive carbon ion beam radiotherapy of 77Gy RBE equivalent per 22 fractions for gross tumor volume The hypoxic lesions dose boost arm will receive 77Gy RBE equivalent per 22 fractions for gross tumor volume and a simultaneously dose boost of 836Gy RBE equivalent per 22 fractions for hypoxic lesions detected by 18F-Misonidazole PETCT
Researchers will compare the local progression-free survival of two groups primary endpoint progression-free survival secondary endpoint overall survival secondary endpoint response rate secondary endpoint factional hypoxia volume FHV reduction rate secondary endpoint and toxicities secondary endpoint
Researchers will compare the local progression-free survival of two groups primary endpoint progression-free survival secondary endpoint overall survival secondary endpoint response rate secondary endpoint factional hypoxia volume FHV reduction rate secondary endpoint and toxicities secondary endpoint
Detailed Description:
None
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