Trial Title:
Spatial Location of Breast Cancer Local Recurrence After Mastectomy
NCT ID:
NCT06130111
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Recurrence
Conditions: Keywords:
Mastectomy
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Mastectomy
Description:
Mastectomy as a surgical procedure for breast cancer (regardless of perioperative
treatment).
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).
Detailed 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).
Criteria for eligibility:
Study pop:
We aim to include all breast cancer patients treated with mastectomy in the Netherlands
between 2003- 2008, and known to have experienced a local or regional recurrence or
distant metastases as the first site of failure.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age 18 years and more at the time of breast cancer diagnosis.
- Proven histology of first invasive breast cancer
- Mastectomy as a surgical procedure for breast cancer (regardless of perioperative
treatment).
- Having a local recurrence, as primary event
- reast cancer diagnosis in the period 2003-2008.
Exclusion Criteria:
- Non-epithelial histology.
- Primary metastatic breast cancer.
- Mastectomy for breast cancer recurrence after earlier breast conserving therapy.
- Synchronous breast cancer.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
Maastro
Address:
City:
Maastricht
Zip:
6229ET
Country:
Netherlands
Start date:
September 1, 2021
Completion date:
January 1, 2024
Lead sponsor:
Agency:
Maastricht Radiation Oncology
Agency class:
Other
Collaborator:
Agency:
Albert Schweitzer Hospital
Agency class:
Other
Collaborator:
Agency:
Canisius-Wilhelmina Hospital
Agency class:
Other
Collaborator:
Agency:
Diakonessenhuis, Utrecht
Agency class:
Other
Collaborator:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Franciscus Gasthuis
Agency class:
Other
Collaborator:
Agency:
Haaglanden Medical Centre
Agency class:
Other
Collaborator:
Agency:
Jeroen Bosch Ziekenhuis
Agency class:
Other
Collaborator:
Agency:
Maastricht University Medical Center
Agency class:
Other
Collaborator:
Agency:
Maxima Medical Center
Agency class:
Other
Collaborator:
Agency:
St. Antonius Hospital
Agency class:
Other
Collaborator:
Agency:
Laurentius ziekenhuis
Agency class:
Other
Collaborator:
Agency:
VieCuri Medical Centre
Agency class:
Other
Collaborator:
Agency:
NKI-AvL
Agency class:
Other
Collaborator:
Agency:
Ziekenhuis Netwerk Antwerpen (ZNA)
Agency class:
Other
Collaborator:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
Sheba Medical Center
Agency class:
Other
Collaborator:
Agency:
University of Florence
Agency class:
Other
Source:
Maastricht Radiation Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06130111
