No registrations found.
ID
Source
Brief title
Health condition
Breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
toxicity, scored according to the CTCAE v5.0 (dermatitis, breast pain and fibrosis).
Secondary outcome
cosmetic results, rated by the patient and physician, and recurrence rates
Background summary
Rationale: Erasmus MC Cancer Institute introduced accelerated partial breast irradiation (APBI) using Cyberknife (CK). Short term results regarding patient satisfaction and oncological outcomes are promising, but there is limited knowledge on the long term toxicity and recurrence rate of this treatment.
Objective: To assess acute and late toxicity after CK-APBI in terms of dermatitis, pain, fibrosis, cosmetic results and the rate of recurrence up to 5 years after CK-APBI.
Study design: Prospective, single center, observational cohort study.
Study population: Female patients with early stage low-risk breast cancer
Intervention: none
Main study parameters/endpoints: Primary outcome is toxicity, scored several moments during follow-up according to the CTCAE v5.0 (dermatitis, breast pain and fibrosis). Secondary outcomes are cosmetic results, rated by the patient and physician. Futhermore, recurrence rate will be assessed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is an observational study without any burden to the patient. There is no benefit nor risk for the participants. The results will be used to improve the treatment for future early-stage breast cancer patients.
Study objective
The long term outcome of CK-APBI is good
Study design
2 weeks, 3, 6, 12 and 36 months
Inclusion criteria
• Female
• Intention to treat with CK-APBI at Erasmus MC
• Written informed consent
Exclusion criteria
None
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7871 |
Other | METC Erasmus MC : to be decided |