Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443359
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER
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:
This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients After enrollment participants will be stratified into 2 Groups based on the extent of axillary surgery Participants will complete activities and assessments at baseline and after completion of treatment at 1-2 weeks 3 months 6 months 1 year 2 year and 3 years following completion of treatment
Detailed Description:
This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients Participants are stratified into 2 Groups based on the extent of axillary surgery after enrollment
Group 1 sentinel lymph node procedure with or without select removal of clipped clinically involved lymph nodes
Group 2 axillary lymph node dissection with or without sentinel lymph node procedure or patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2
Participants will complete activities and assessments at baseline and after completion of treatment at 1-2 weeks 3 months 6 months 1 year 2 year and 3 years following completion of treatment At baseline consultations history and physical lymphedema assessment toxicity assessment photographs optional patient-reported outcome questionnaire and radiation simulation will be completed Hypofractionated radiation therapy will be completed weekly through the end of treatment with toxicity assessments At the 1-2 week follow up toxicity assessment photographs optional and the patient-reported outcome questionnaire will be completed At the 3 month 6 month 1 year 2 year and 3 year follow-ups a lymphedema assessment toxicity assessment photographs optional patient-reported outcome questionnaire and follow up examination will be completed
All patients will receive a dose of 4256 Gy in 16 daily fractions to the whole breast or chest wall and regional lymph nodes A boost dose of 10 or 125 Gy in 4 or 5 daily fractions of 25 Gy respectively will be administered to either the lumpectomy cavity or mastectomy scar as appropriate Critical organs will be contoured into the treatment planning such as the heart left anterior descending artery ipsilateral lung
Patients may receive neoadjuvant or adjuvant systemic treatment on this trial In general the patient should receive systemic treatment according to the current standard of care at the time of enrollment taking into account the discretion of the treating medical oncologist
Expected radiation-related acute adverse events ie those experienced within the first 6 months following treatment are similar to those with conventionally fractionated radiotherapy and include fatigue and tenderness pruritus hyperpigmentation hypopigmentation dry desquamation and moist desquamation of the skin Potential late effects of radiation include arm lymphedema shoulder stiffness fibrosis of normal tissue telangiectasia hyperpigmentation or hypopigmentation of the skin brachial plexopathy myositis rib fracture pneumonitis second malignancy or cardiomyopathy The participants will be monitored for adverse events during radiotherapy and following radiotherapy
Group 1 sentinel lymph node procedure with or without select removal of clipped clinically involved lymph nodes
Group 2 axillary lymph node dissection with or without sentinel lymph node procedure or patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2
Participants will complete activities and assessments at baseline and after completion of treatment at 1-2 weeks 3 months 6 months 1 year 2 year and 3 years following completion of treatment At baseline consultations history and physical lymphedema assessment toxicity assessment photographs optional patient-reported outcome questionnaire and radiation simulation will be completed Hypofractionated radiation therapy will be completed weekly through the end of treatment with toxicity assessments At the 1-2 week follow up toxicity assessment photographs optional and the patient-reported outcome questionnaire will be completed At the 3 month 6 month 1 year 2 year and 3 year follow-ups a lymphedema assessment toxicity assessment photographs optional patient-reported outcome questionnaire and follow up examination will be completed
All patients will receive a dose of 4256 Gy in 16 daily fractions to the whole breast or chest wall and regional lymph nodes A boost dose of 10 or 125 Gy in 4 or 5 daily fractions of 25 Gy respectively will be administered to either the lumpectomy cavity or mastectomy scar as appropriate Critical organs will be contoured into the treatment planning such as the heart left anterior descending artery ipsilateral lung
Patients may receive neoadjuvant or adjuvant systemic treatment on this trial In general the patient should receive systemic treatment according to the current standard of care at the time of enrollment taking into account the discretion of the treating medical oncologist
Expected radiation-related acute adverse events ie those experienced within the first 6 months following treatment are similar to those with conventionally fractionated radiotherapy and include fatigue and tenderness pruritus hyperpigmentation hypopigmentation dry desquamation and moist desquamation of the skin Potential late effects of radiation include arm lymphedema shoulder stiffness fibrosis of normal tissue telangiectasia hyperpigmentation or hypopigmentation of the skin brachial plexopathy myositis rib fracture pneumonitis second malignancy or cardiomyopathy The participants will be monitored for adverse events during radiotherapy and following radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None