Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464913
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Randomized Phase II Trial Chest Wall RT Omission After Prosthetic Reconstruction
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
A Randomized Phase II Trial on Omission of Chest Wall Radiotherapy After Implant-Based Breast Reconstruction in Early Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this randomized Phase II clinical trial is to test the effects of omitting chest wall radiotherapy RT after prosthetic reconstruction in early-stage breast cancer patients The main questions it aims to answer are
Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate
Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness
Participants will
Be randomly assigned to one of two groups
One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas
The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas
Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates
If there is a comparison group Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks
Can omitting chest wall RT after prosthetic reconstruction reduce the failure rate of breast reconstruction without significantly increasing the local recurrence rate
Does this approach ensure an improvement in the quality of life for patients without sacrificing therapeutic effectiveness
Participants will
Be randomly assigned to one of two groups
One group will receive standard RT to the chest wall and supraclavicular and infraclavicular lymphatic drainage areas
The other group will have chest wall RT omitted and will only receive RT to the supraclavicular and infraclavicular lymphatic drainage areas
Participate in follow-up assessments to monitor reconstruction failure rates and local recurrence rates
If there is a comparison group Researchers will compare the outcomes of the two groups to evaluate the impact of chest wall RT omission on reconstruction failure and local recurrence risks
Detailed Description:
Breast reconstruction as part of the surgical treatment for breast cancer offers an opportunity for patients who have undergone mastectomy to restore their body image and mental state while post-mastectomy radiation therapy PMRT has advantages in local control and long-term survival of breast cancer However the integration of PMRT with reconstruction especially using implants raises concerns due to potential complications and the risk of reconstruction failure
Reconstruction methods include autologous tissue and prosthetic implants with the latter becoming more popular due to shorter surgery times and faster recovery The choice between immediate delayed and two-stage reconstruction depends on tumor characteristics and patient factors PMRT indications are based on tumor features and risks The 2019 ESTRO expert consensus pointed out that the radiotherapy target area after breast prosthetic implantation should include the chest wall and all high-risk lymphatic drainage areas of the axillary region that have not been removed While PMRT improves outcomes it increases complications in implant-based reconstructions Within two years after prosthetic reconstruction surgery the proportion of patients who have at least one complication after radiotherapy is 39 while it is 22 for patients who have not received radiotherapy Early complications include fat or flap necrosis thrombosis infection hematoma delayed wound healing and late complications include pain prosthetic contracture prosthetic exposure or rupture and a decline in various indicators of aesthetic results Patients who ultimately have to remove the implant or convert to autologous tissue reconstruction due to severe complications are defined as reconstruction failure Among patients who received implant reconstruction and radiotherapy the proportion of reconstruction failure after two years is the highest 187 in contrast the failure rate in the non-radiotherapy group or autologous reconstruction group is less than 5
Considering the high incidence of complications after prosthetic implantation the failure rate of breast reconstruction may exceed 20 while the local recurrence rate after breast reconstruction surgery is around 5 For early-stage breast cancer patients undergoing cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction whether omitting chest wall radiotherapy can reduce the failure of reconstruction without significantly increasing the local recurrence rate to ensure that improving the quality of life for patients does not sacrifice therapeutic effects In response to this issue this project proposes a randomized Phase II clinical trial of omitting chest wall radiotherapy after prosthetic reconstruction in early-stage breast cancer prospective study This study will adopt a randomized controlled method dividing patients into two groups one group receiving routine chest wall plus supraclavicular and infraclavicular lymphatic drainage area radiotherapy and the other group omitting chest wall radiotherapy and only receiving supraclavicular and infraclavicular lymphatic drainage area radiotherapy aiming to evaluate the impact of omitting chest wall radiotherapy in PMRT after prosthetic reconstruction on the reconstruction failure rate of breast cancer patients without significantly increasing the risk of local recurrence
Reconstruction methods include autologous tissue and prosthetic implants with the latter becoming more popular due to shorter surgery times and faster recovery The choice between immediate delayed and two-stage reconstruction depends on tumor characteristics and patient factors PMRT indications are based on tumor features and risks The 2019 ESTRO expert consensus pointed out that the radiotherapy target area after breast prosthetic implantation should include the chest wall and all high-risk lymphatic drainage areas of the axillary region that have not been removed While PMRT improves outcomes it increases complications in implant-based reconstructions Within two years after prosthetic reconstruction surgery the proportion of patients who have at least one complication after radiotherapy is 39 while it is 22 for patients who have not received radiotherapy Early complications include fat or flap necrosis thrombosis infection hematoma delayed wound healing and late complications include pain prosthetic contracture prosthetic exposure or rupture and a decline in various indicators of aesthetic results Patients who ultimately have to remove the implant or convert to autologous tissue reconstruction due to severe complications are defined as reconstruction failure Among patients who received implant reconstruction and radiotherapy the proportion of reconstruction failure after two years is the highest 187 in contrast the failure rate in the non-radiotherapy group or autologous reconstruction group is less than 5
Considering the high incidence of complications after prosthetic implantation the failure rate of breast reconstruction may exceed 20 while the local recurrence rate after breast reconstruction surgery is around 5 For early-stage breast cancer patients undergoing cold knife one-step prosthetic reconstruction or two-step expander-prosthetic reconstruction whether omitting chest wall radiotherapy can reduce the failure of reconstruction without significantly increasing the local recurrence rate to ensure that improving the quality of life for patients does not sacrifice therapeutic effects In response to this issue this project proposes a randomized Phase II clinical trial of omitting chest wall radiotherapy after prosthetic reconstruction in early-stage breast cancer prospective study This study will adopt a randomized controlled method dividing patients into two groups one group receiving routine chest wall plus supraclavicular and infraclavicular lymphatic drainage area radiotherapy and the other group omitting chest wall radiotherapy and only receiving supraclavicular and infraclavicular lymphatic drainage area radiotherapy aiming to evaluate the impact of omitting chest wall radiotherapy in PMRT after prosthetic reconstruction on the reconstruction failure rate of breast cancer patients without significantly increasing the risk of local recurrence
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