Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321653
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Brief Title:
Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
AXILL-ART Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes Without Axillary Dissection in Breast Cancer Conservative Surgery Observational Study
Status:
RECRUITING
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:
AXILL-ART
Brief Summary:
In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative scheduled for conservative surgery and Sentinel Node Biopsy SNB are enrolled in the protocol if they have 1-2 sentinel lymphnodes SLNs with macrometastases SLN status will be checked on definitive sections
Detailed Description:
In recent years breast oncologic surgery has aimed to omit axillary dissection in cases where no more than two sentinel lymph nodes are positive particularly when complementary radiotherapy to the whole breast is planned
Radiation therapy to the axillary lymph nodes ensures excellent locoregional control in patients with primary tumor no more than 5 centimeter and 1-2 macrometastatic sentinel lymph nodes and appears to carry fewer side effects than axillary dissection
Arm lymphedema is indeed one of the most well-known long-term complications of breast cancer treatment impacting the quality of life for patients undergoing lymphadenectomy In this scenario the study proposes a treatment of hypofractionated intensity-modulated radiotherapy IMRT to the breast and axillary lymph nodes with the aim of further containing the risk of developing ipsilateral arm lymphedema IMRT improves the dosimetric profile of surrounding organs at risk in the treated area with better dose conformity to the target volume compared to tangential fields used in conventional 3D conformal techniques as employed in most trials described so far
Radiation therapy to the axillary lymph nodes ensures excellent locoregional control in patients with primary tumor no more than 5 centimeter and 1-2 macrometastatic sentinel lymph nodes and appears to carry fewer side effects than axillary dissection
Arm lymphedema is indeed one of the most well-known long-term complications of breast cancer treatment impacting the quality of life for patients undergoing lymphadenectomy In this scenario the study proposes a treatment of hypofractionated intensity-modulated radiotherapy IMRT to the breast and axillary lymph nodes with the aim of further containing the risk of developing ipsilateral arm lymphedema IMRT improves the dosimetric profile of surrounding organs at risk in the treated area with better dose conformity to the target volume compared to tangential fields used in conventional 3D conformal techniques as employed in most trials described so far
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