Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06583655
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-01
Brief Title:
Precision Regional Node Irradiation for Sentinel Node-positive Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Study of Individualized Regional Node Irradiation for Sentinel Node-positive Breast Cancer Without Axillary Dissection Based on Clinical and Genomic Risk Assessment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Axillary lymph node dissection has long been regarded as standard if treatment of the axilla is indicated for patients with a positive sentinel node Although axillary lymph node dissection provides excellent regional control it is associated with harmful side-effects Since the publication of IBCSG23-01 ACOSOG Z0011 and AMAROS study these studies indicated that there was no significant difference in recurrence and overall survival rates between the ALNB and SLNBALND followed by adjuvant radiotherapy Therefore an adaptation of the strategy to omit axillary lymph node dissection in patients with low-risk axillary involvement who are treated with curative surgery and systematic therapy However they also pose new challenges for adjuvant radiotherapy decisions In the Z0011 study patients were required to receive breast tangent field radiotherapy In the AMAROS study axillary radiotherapy included level I-III axillary lymph node drainage areas and the supraclavicular area but the study results showed a local recurrence rate of only 119 at 5 years in the axillary radiotherapy group Consequently there is considerable controversy among clinical experts about whether a combined regional lymphatic drainage area radiotherapy strategy is necessary for low-burden sentinel lymph node metastasis breast cancer patients In contrast results from the EORTC-22922 and MA-20 studies which included patients undergoing axillary lymph node dissection showed that adjuvant radiotherapy to the entire lymphatic drainage area including the internal mammary region reduced the risk of disease-free survival and breast cancer-specific mortality Therefore the adjuvant radiotherapy strategy for early breast cancer patients with low-burden sentinel lymph node metastasis remains controversial with a lack of high-level evidence to support it
Detailed Description:
None
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