Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418210
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2007-01-02
Brief Title:
Accelerated Partial Breast Irradiation for Early Breast Cancer
Sponsor:
Trans Tasman Radiation Oncology Group
Organization:
Trans Tasman Radiation Oncology Group
Study Overview
Official Title:
A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-12
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:
Hypothesis
In selected women with node-negative invasive breast cancer treated with breast conserving surgery postoperative accelerated partial breast irradiation APBI limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy 3D CRT is technically feasible and reproducible with acceptable treatment toxicity cosmetic outcome and local control rate in a multicentre trial
In selected women with node-negative invasive breast cancer treated with breast conserving surgery postoperative accelerated partial breast irradiation APBI limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy 3D CRT is technically feasible and reproducible with acceptable treatment toxicity cosmetic outcome and local control rate in a multicentre trial
Detailed Description:
This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins
This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT This is defined as the proportion of eligible patients treated without a major protocol deviation Secondary endpoints include radiation toxicity cosmetic outcome quality of life time to ipsilateral breast recurrence disease-free survival and overall survival
Primary objectives To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery
Secondary objectives
To assess the acute and long term toxicity of APBI using 3D CRT
To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT
To determine the time to ipsilateral breast recurrence disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT
To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT
This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT This is defined as the proportion of eligible patients treated without a major protocol deviation Secondary endpoints include radiation toxicity cosmetic outcome quality of life time to ipsilateral breast recurrence disease-free survival and overall survival
Primary objectives To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery
Secondary objectives
To assess the acute and long term toxicity of APBI using 3D CRT
To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT
To determine the time to ipsilateral breast recurrence disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT
To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACTRN12607000238471 | REGISTRY | ANZ CTR | None |