Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605521
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-06
Brief Title:
To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients A Prospective Multicenter Non-interventionist Real World Study
Status:
RECRUITING
Status Verified Date:
2024-02
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:
For newly diagnosed ISLNM breast cancer on the basis of effective treatment of the new auxiliary system the optimal local treatment of the supraclavicular region remains controversial Although guidelines such as NCCN recommend simple clavicular radiation therapy there are studies suggesting that supraclavicular lymph node dissection can improve prognosis and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection Therefore ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer The effectiveness and safety of stage IIIc treatment still require prospective research to confirmThis project is a prospective multicenter non-interference real world study In the real world study the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients
Detailed Description:
For newly diagnosed ISLNM breast cancer on the basis of effective treatment of the new auxiliary system the optimal local treatment of the supraclavicular region remains controversial Although guidelines such as NCCN recommend simple clavicular radiation therapy there are studies suggesting that supraclavicular lymph node dissection can improve prognosis and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection Therefore ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer The effectiveness and safety of stage IIIc treatment still require prospective research to confirmThis project is a prospective multicenter non-interference real world study In the real world study the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients
The main endpoint of the study was recurrence free survival on the ipsilateral clavicle The secondary study endpoint is disease-free survival Ipsilateral supraclavicular relapse-free survival Rregional lymph node relapse-free survival Overall survival Security The incidence of upper limb lymphedema Patients quality of life
The main endpoint of the study was recurrence free survival on the ipsilateral clavicle The secondary study endpoint is disease-free survival Ipsilateral supraclavicular relapse-free survival Rregional lymph node relapse-free survival Overall survival Security The incidence of upper limb lymphedema Patients quality of life
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