Viewing Study NCT01290835


Ignite Creation Date: 2025-12-24 @ 10:09 PM
Ignite Modification Date: 2025-12-27 @ 7:16 PM
Study NCT ID: NCT01290835
Status: COMPLETED
Last Update Posted: 2025-08-15
First Post: 2011-02-04
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Sponsor: Essentia Health
Organization:

Study Overview

Official Title: Conformal Partial Breast Irradiation With CyberKnife After Resection for Early Stage Breast Cancer
Status: COMPLETED
Status Verified Date: 2025-08
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: CKPBI
Brief Summary: The purpose of this study is to determine if it is feasible, safe, and effective to use Cyberknife radiotherapy to deliver partial breast radiotherapy after lumpectomy.Patients meeting eligibility criteria will be invited to participate. Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions. Short-term and long-term toxicity will be assessed as well as Tumor control and site of failure (if any).
Detailed Description: This study will determine the feasibility and toxicity of a short course of accelerated radiotherapy as adjuvant treatment for early stage breast cancer. Successful completion of this project may provide a rationale to offer this treatment for select patients with the benefit of potentially less tissue damage and a shorter overall course of therapy. These improvements may ultimately allow more patients the opportunity of breast conserving therapy to treat their cancer

Study Oversight

Has Oversight DMC: False
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?: