Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404697
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-05
Brief Title:
Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Evaluating the Efficacy and Safety of Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients According to Nodal Response a Single-arm Prospective Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
cN3c breast cancer with ipsilateral supraclavicular SCV lymph nodal SCLN metastasis is known to have a dismal prognosis Currently the combined-modality therapy consisting of primary systemic therapy PST subsequent local andor systemic therapy based on response is the standard of care However the value of giving radiotherapy RT boost to SCV region remains uncertain in cN3c patients This study aimed to assess the efficacy and safety of RT boost to the SCV area in high-risk cN3c breast cancer patients based on nodal response following PST
Detailed Description:
This study is a phase II single-arm prospective clinical trial aimed at assessing the efficacy and safety of RT boost to the SCV area among high-risk cN3c breast cancer patients contingent upon the nodal response after PST
Our previous retrospective study revealed that nodal response to PST serves as an independent prognostic factor for survival and pattern of failure A cumulative SCV dose of 60 Gy has been associated with improved overall survival OS in subgroup of patients who did not achieve SCLN cCR
Based on nodal response to PST patients will be categorized into three groups those who did not achieve cCR in SCLN considered high risk those who achieved SCLN cCR but did not attain pCR in ALN considered intermediate risk and those who achieved cCR in SCLN and pCR in ALN considered low risk High-risk patients will undergo boost irradiation to the SCV with a cumulative dose of 60 Gy
Our previous retrospective study revealed that nodal response to PST serves as an independent prognostic factor for survival and pattern of failure A cumulative SCV dose of 60 Gy has been associated with improved overall survival OS in subgroup of patients who did not achieve SCLN cCR
Based on nodal response to PST patients will be categorized into three groups those who did not achieve cCR in SCLN considered high risk those who achieved SCLN cCR but did not attain pCR in ALN considered intermediate risk and those who achieved cCR in SCLN and pCR in ALN considered low risk High-risk patients will undergo boost irradiation to the SCV with a cumulative dose of 60 Gy
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