None listed
Conditions
Brief summary
The study is evaluating the feasibility of accelerated partial breast irradiation (APBI) in women with breast cancer. Who is it for? You may be eligible to join this study if you are a woman above 50 years of age who has been diagnosed with early or local breast cancer. Trial details: All participants in this study will undergo a procedure called accelerated partial breast irradiation (APBI). This involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic. These catheters will remain in situ for 7 days. The catheters are then connected to a computerised machine which remotely loads a high dose rate radioactive source into the catheters and determines the amount of time that the source remains in each specific dwell position. In doing so, the dose of radiation is individually tailored to target the areas which are at the highest risk of disease recurrence whilst minimising dose to the surrounding normal structures such as the lungs, heart and contralateral breast. Treatment is delivered twice daily over 5 days in total with the catheters. Each treatment will take 10-15 minutes with an inter-fraction interval of at least 6 hours. Participants will be assessed post treatment, and at 6 weeks, 6 months, 1 year, and annually thereafter for up to 10 years in order to evaluate the safety of the procedure and effect on cosmetic outcomes, quality of life and cancer recurrence.
Interventions
We are testing the feasibility of using Accelerated Partial Breast Irradiation (APBI) to deliver adjuvant radiation to only the breast tissue surrounding the surgical excision cavity. This is different to the normal external beam radiation approach whereby the entire affected breast is treated.
The procedure involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic and ultras
We are testing the feasibility of using Accelerated Partial Breast Irradiation (APBI) to deliver adjuvant radiation to only the breast tissue surrounding the surgical excision cavity. This is different to the normal external beam radiation approach whereby the entire affected breast is treated. The procedure involves the insertion of approximately 10 to 25 hollow plastic tubes (catheters) into the region surrounding the surgical excision cavity of the breast under general anaesthetic and ultrasound guidance. These catheters will remain in situ for 7 days. The catheters are then connected to a computerised machine which remotely controls the movement of a high dose rate radioactive source into the catheters and determines the exact amount of radiation given (3.4Gy per fraction). In doing so, the dose of radiation is individually tailored to target the areas which are at the highest risk of disease recurrence whilst minimising dose to the surrounding normal structures. The treatment time is truncated from approximately 15 to 30 daily treatments for external beam radiotherapy (depending on individual patient factors and institutional protocols) to twice daily treatments with an inter-fraction interval of at least 6 hours over 5 days in total for APBI. Each treatment lasts for 10-15mins. It is hoped that this logistical advantage will improve the acceptability of adjuvant radiotherapy and consequently increase the numbers of women who opt for breast conservation treatment.
Sponsors
Dr Yaw Chin.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
a) Females more than 50 years of age. b) Performance status 0-2. c) Unicentric, invasive ductal carcinoma measuring 3cm in maximal diameter or less. d) Negative surgical resection margins, defined as no tumour at the inked margins. e) No extensive intraductal component, as defined by >25% of the invasive ductal tumour being comprised of intraductal carcinoma or ductal carcinoma in-situ being also present in the adjacent breast tissue. f) No lymphovascular invasion. g) No cutaneous involvement, including Paget’s disease of the nipple, oedema (peau d’orange) or inflammatory carcinoma. h) No axillary nodal involvement on sentinel node biopsy or axillary nodal dissection. i) No distant metastases. j) A clearly defined surgical excision cavity and a planning target volume to whole breast volume ratio of >25%, based on the postoperative CT scan. k) Provision of verbal and written consent, including willingness to comply with the specified treatment protocol, follow-up visits and examinations.
Exclusion criteria
a) Locally recurrent breast cancer. b) History of concurrent or previous malignancies (except for non-melanomatous skin cancer or carcinoma in-situ of the uterine cervix). c) Her-2 receptor positive tumours. d) Microscopic assessment of tumour resection margins cannot be defined accurately. e) Women who are pregnant or lactating. f) Pre-existing connective tissue disorder such as scleroderma, systemic lupus erythematosis and dermatomyositis. g) Patients with ipsilateral breast implants. h) Previous radiation treatment to the ipsilateral breast or thoracic region. i) Psychiatric or addictive disorders that preclude patients from giving informed consent.
Outcome results
None listed