Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02314364
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2014-11-20
Brief Title:
A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Trial of Integrating Stereotactic Body Radiation Therapy With Selective Targeted Therapy in Stage IV Oncogene-driven Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2024-03
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 research study is studying a type of radiation therapy called Stereotactic Body Radiation Therapy SBRT as a possible treatment for stage IV non-small cell lung cancer NSCLC that has a mutated epidermal growth factor receptor EGFR or or displaced anaplastic lymphoma receptor tyrosine kinase ALK or ROS proto-oncogene 1 ROS1 gene oncogene-driven NSCLC and for which the subject has been receiving treatment with a targeted biological agent such as erlotinib crizotinib or other drugs
Detailed Description:
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease The investigational intervention in this study is SBRT with proton or photon radiation explained below Investigational means that the intervention is being studied SBRT and proton radiation therapy are FDA approved radiation delivery systems However using it as a treatment for stage IV NSCLC is still investigational
SBRT is a specialized technologically advanced type of external beam radiation therapy that pinpoints high doses of radiation directly on the cancer Because of high precision these treatments spare healthy tissue and are associated with fewer side effects SBRT is very different from conventional therapy where radiation is delivered in small doses given daily over the course of several weeks For SBRT the total dose of radiation is typically administered in 4-5 daily sessions SBRT can be delivered with standard so called photon radiation or proton beam Neither of these two types of radiation is generally superior over the other There are technical differences between these two and depending on tumor location size shape and other factors the investigators will decide which type of radiation to use for which treatment
After the screening procedures confirm you are eligible to participate in the research study
- Each participant will receive stereotactic treatment course SBRT with protons or photons to the area of their tumor
SBRT is a specialized technologically advanced type of external beam radiation therapy that pinpoints high doses of radiation directly on the cancer Because of high precision these treatments spare healthy tissue and are associated with fewer side effects SBRT is very different from conventional therapy where radiation is delivered in small doses given daily over the course of several weeks For SBRT the total dose of radiation is typically administered in 4-5 daily sessions SBRT can be delivered with standard so called photon radiation or proton beam Neither of these two types of radiation is generally superior over the other There are technical differences between these two and depending on tumor location size shape and other factors the investigators will decide which type of radiation to use for which treatment
After the screening procedures confirm you are eligible to participate in the research study
- Each participant will receive stereotactic treatment course SBRT with protons or photons to the area of their tumor
Study Oversight
Has Oversight DMC:
None
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?:
None