A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Trans Tasman Radiation Oncology Group
- Enrollment
- 48
- Locations
- 7
- Primary Endpoint
- Feasibility rate of APBI using 3D conformal radiation therapy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
Hypothesis:
In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.
Detailed Description
This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins. This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and overall survival. Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery. Secondary objectives: * To assess the acute and long term toxicity of APBI using 3D CRT. * To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT. * To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT. * To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must fulfill all of the following criteria for admission to study:
- •Women aged \>= 50 years.
- •Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
- •Bilateral mammograms performed within 6 months prior to registration.
- •Treated with breast conserving surgery (primary excision or re-excision) with negative radial resection margins of \>= 2 mm\* for both the invasive and if present, associated intraductal tumour.
- •\*Patients with superficial or deep resection margin of \< 2 mm are eligible if surgery has removed all of the intervening breast tissue from the subcutaneous tissue to the pectoralis fascia.
- •Unifocal tumour measuring ≤ 20 mm in maximum microscopic dimension.
- •Negative nodal status determined by sentinel node biopsy, axillary dissection, or for women \> 70 years of age, clinical examination.
- •No evidence of distant metastasis.
- •Assessed by surgeon and radiation oncologist to be suitable for breast conserving therapy.
Exclusion Criteria
- •Patients who fulfill any of the following criteria are not eligible for admission to study:
- •Multifocal or multicentric tumours.
- •Clinical or pathologic evidence of any of the following tumour features: extension to chest wall (excluding pectoralis muscle); oedema (including peau d'orange) or ulceration of skin; satellite skin nodules confined to the same breast; and inflammatory carcinoma.
- •Presence of extensive intraductal component (ductal carcinoma in situ occupying \> 25% of the primary invasive tumour and present adjacent to the primary tumour).
- •Node-positive breast cancer determined by sentinel node biopsy, axillary dissection, or in women \> 70 years of age, clinical examination.
- •Inability to localise surgical cavity on CT scans with no evidence of a surgical cavity, seroma or surgical clips delineating the tumour bed.
- •Treatment target volume estimated to occupy \> 25% of the ipsilateral whole breast volume.
- •Synchronous or metachronous bilateral invasive or intraductal breast cancer.
- •Locally recurrent breast cancer.
- •Ipsilateral breast implant.
Outcomes
Primary Outcomes
Feasibility rate of APBI using 3D conformal radiation therapy
Time Frame: First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial)
Secondary Outcomes
- Overall survival(A final analysis will occur when all patients have been followed up for 5 years.)
- Radiation toxicity(First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.)
- Disease free survival(First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.)
- Cosmetic outcome(First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial))
- Quality of life(First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.)
- Time to ipsilateral breast recurrence(First analysis will occur 5 years after accrual of all patients (approximately 6 years after start of trial). A final analysis will occur when all patients have been followed up for 5 years.)