This study investigates 3 different aspects of RFA treatment:1. Feasibility and safety of RFA treatment in elderly patients ( > 70 years) with T1 breast carcinoma who are not or less fit for surgery.2. Efficacy of RFA treatment in elderly…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Feasibility of RFA
-Safety of RFA with registration of complications
-Efficacy RFA with evaluating possible local tumor recurrence in the breast by
MRI and core needle biopsies
-Tumor recurrence (other organ than breast)
-Patients experience (see also appendix 3 en 4)
Secondary outcome
n.a.
Background summary
Breast carcinoma is a common disease. 30% of patients wirh breast carcinoma are
older than 70 years. Most of these patients are treated with breast
conservative surgery or ablation in combination with a sentinel-node procedure.
Some patients are not or less fit for surgery. In these patients radiofrequency
ablation can be applied to achieve local tumor control. RFA is a minimally
invasive technique which uses needles which are placed in the tumor. An
alternating current in the needle causes hyperthermia and destroys the tissue.
This treatment can be performed under local epidural anesthesia.
Study objective
This study investigates 3 different aspects of RFA treatment:
1. Feasibility and safety of RFA treatment in elderly patients ( > 70 years)
with T1 breast carcinoma who are not or less fit for surgery.
2. Efficacy of RFA treatment in elderly patients ( > 70 years)with T1 breast
carcinoma who are not or less fit for surgery.
3. Patients experience study with: VAS pain scale and Quality of life *scores
Study design
observational study
Intervention
Radiofrequency ablation of T1 breast carcinoma (N0M0)
Study burden and risks
There is a relatively low risk of complications associated with the epidural
anesthesia and the RFA treatment of the breast.
The mostly reported complications associated with the RFA treatment of the
breast are pain and skin burns.
After RFA treatment several evalution forms must be filled in( see also
appendix 3 and 4 of the protocol.)
Therapy respons evaluation is performed by MRI (3 x with IV contrast) and
several core needle biopsies after 6 and 12 months
Tolbrugstraat 11, Postbus 90153
5200 ME 's-Hertogenbosch
NL
Tolbrugstraat 11, Postbus 90153
5200 ME 's-Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
-breastcarcinoma (biopsy proven) with positive estrogenreceptorstatus
-tumor:maximal diameter is 2 cm
-due to comorbidity the tumor is not treatable with surgery or patient does not want to receive surgical treatment
-tumor can be localised using ultrasound
-patient is older than 70 years
-informed consent
Exclusion criteria
-multiple carcinomas in the breast
-contra-indications for MR imaging
-hormone receptor negative tumors
-axillary lymph node metastasis
-metastasis in other organs
Design
Recruitment
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 |
|---|---|
| CCMO | NL20184.028.08 |