Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT06130111 |
Other study ID # |
W 21 04 00088 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
January 1, 2024 |
Study information
Verified date |
November 2023 |
Source |
Maastricht Radiation Oncology |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Rationale:To improve the definition of the target volume for radiotherapy of the chestwall
after different types of mastectomy, the exact localization of regions at risk for a local
recurrence should be known. However, there are currently insufficient data in literature
showing where local recurrences occur after different types of mastectomy.
Objective: The primary objective of the proposed study is to determine whether the spatial,
location of a breast cancer recurrence after mastectomy, differs for different types of
mastectomy.
Study design: Retrospective study evaluating spatial location and site of recurrences after
mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with
mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local
recurrence as the first site of failure.
Primary endpoint: Spatial location of local recurrence (e.g., primary tumour bed, scar, skin,
subcutaneous, nipple, areola, pectoral muscles).
Description:
Rationale:To improve the definition of the target volume for radiotherapy of the chestwall
after different types of mastectomy, the exact localization of regions at risk for a local
recurrence should be known. However, there are currently insufficient data in literature
showing where local recurrences occur after different types of mastectomy.
Objective: The primary objective of the proposed study is to determine whether the spatial,
location of a breast cancer recurrence after mastectomy, differs for different types of
mastectomy. Secondary objectives are to assess whether tumour characteristics (e.g.,
molecular subtypes, lymphangio/lymphovascular invasion) and treatment-related factors (e.g.,
PMRTwith or without bolus, radiation volumes, doses) influence the site of recurrence and
spatial location.
Study design: Retrospective study evaluating spatial location and site of recurrences after
mastectomy.
Study population: The investigators aim to include all breast cancer patients treated with
mastectomy in the Netherlands between 2003- 2008, and known to have experienced a local
recurrence as the first site of failure.
Primary endpoint: Primary endpoint: Spatial location of local recurrence (e.g., primary
tumour bed, scar, skin, subcutaneous, nipple, areola, pectoral muscles).
Other study parameters: First descriptive statistics will be performed to investigate whether
there is a relation between the localization of the recurrence and the type of mastectomy:
modified radical mastectomy (MRM), skin-sparing mastectomy (SSM), nipple sparing mastectomy
(NSM).