A Randomised Controlled Trial Comparing Intraoperative To Conventional Radiotherapy In Women With Early Beast Cancer.
Funder
National Health and Medical Research Council
Funding Amount
$874,046.00
Summary
With the advent of breast screening in Australia many women are diagnosed with small low risk cancers that can be treated with breast conserving therapy with good outcomes. Surgery and radiotherapy in this situation are used to minimise the risk of local recurrence. It is now being questioned whether we can tailor radiotherapy to suit individual patients rather than recommending the daily 6-7 weeks of standard external beam radiotherapy to all patients. This trial aims to answer this question as ....With the advent of breast screening in Australia many women are diagnosed with small low risk cancers that can be treated with breast conserving therapy with good outcomes. Surgery and radiotherapy in this situation are used to minimise the risk of local recurrence. It is now being questioned whether we can tailor radiotherapy to suit individual patients rather than recommending the daily 6-7 weeks of standard external beam radiotherapy to all patients. This trial aims to answer this question as a new device which can deliver radiotherapy intraoperatively in a single session has now been tested and proven safe to use in the breast. The main objective of this trial is to demonstrate that a single dose of radiotherapy delivered intraoperatively (IORT) gives an equivalent local control rate to standard external beam radiotherapy in women with early low risk breast cancer who are suitable for breast conserving therapy. Other objectives include comparing the two treatments with respect to; disease-free-overall survival, cosmetic outcome, patient satisfaction-preference, quality of life and cost benefit. If the study finds that IORT alone after breast conserving surgery is as effective in achieving local control as standard external beam radiotherapy, a major benefit to patients would be shorter treatment duration by avoiding the 6-7 weeks of standard radiotherapy. A reduction in the number of early breast cancer patients requiring access to standard radiotherapy would also benefit treatment centres and other cancer patients by reducing the waiting times for radiotherapy. Consumer groups have supported the concept from the beginning and there has been recent increase in level of support by originally unsupportive groups. Of great significance is this trial offers an opportunity to formally investigate the efficacy of delivering IORT in the safe confines of a clinical trial, before allowing it to become a standard treatment which is occurring in other countries.Read moreRead less
A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Non-low Risk Ductal Carcinoma In Situ Of The Breast
Funder
National Health and Medical Research Council
Funding Amount
$658,419.00
Summary
After surgery to remove ductal carcinoma in situ (DCIS), a pre-invasive form of breast cancer, radiotherapy to the breast decreases the risk of recurrence. The study investigates if a higher radiation dose to the tumour bed improves tumour control, and if a shorter course of radiotherapy is as effective as the standard longer course. It also assesses quality of life consequences of treatment and tests biomarkers that may predict the risk of recurrence in individual patients.
A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules In Non-low Risk DCIS Of The Breast
Funder
National Health and Medical Research Council
Funding Amount
$1,751,209.00
Summary
Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed i ....Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed in higher-risk women increases tumour control. It is also uncertain if giving fewer but larger radiation doses over 3-4 weeks would achieve the same tumour control as the standard 5-7 week course of RT to improve patient convenience and access to RT. Thus, this multicentre study of 610 women with higher-risk DCIS will investigate if adding a tumour bed radiation boost after whole breast RT improves tumour control, and the shorter RT course achieves the same tumour control as the standard longer course. Currently, the ability to predict the malignant potential of DCIS and RT toxicity is limited. This study will investigate if there are biological and genetic markers predictive of invasive recurrence and normal tissue toxicity in women with DCIS using state of the art technology. Women need to weigh up the likelihood of cancer control against adverse treatment effects to make an informed treatment decision. However, very little is known about the quality of life (QoL) consequences of the diagnosis and treatment of DCIS. In this study, the QoL, psychological distress, perceived risk of invasive cancer recurrence and perceived cosmetic outcomes of women with DCIS, will be assessed using a questionnaire of validated measures. This study will refine treatment for women with DCIS according to their risks of recurrence. It will significantly advance the understanding of the biology of DCIS and its psychological and QoL outcomes after treatment.Read moreRead less
A Multicentre Feasibility Study Of Partial Breast Irradiation Using 3D Conformal Radiotherapy For Early Breast Cancer
Funder
National Health and Medical Research Council
Funding Amount
$154,910.00
Summary
Breast conserving therapy (BCT) is an accepted treatment option for most women with early breast cancer. Whole breast irradiation (WBI) after breast conserving surgery substantially reduces the risk of breast recurrence. However, the prolonged 5-7 week course of WBI substantially decreases the quality of life (QoL) experienced by women and is a logistical problem particularly for the elderly and women who reside far from a radiotherapy (RT) facility. In order to improve the access and convenienc ....Breast conserving therapy (BCT) is an accepted treatment option for most women with early breast cancer. Whole breast irradiation (WBI) after breast conserving surgery substantially reduces the risk of breast recurrence. However, the prolonged 5-7 week course of WBI substantially decreases the quality of life (QoL) experienced by women and is a logistical problem particularly for the elderly and women who reside far from a radiotherapy (RT) facility. In order to improve the access and convenience of BCT, accelerated partial breast irradiation (APBI) is being investigated. Research shows that 75% of the breast recurrences occur at the tumour bed after BCT implying that in selected women, RT may be limited to the tumour bed only. By limiting the breast volume irradiated, it is feasible to accelerate radiation dose delivery and reduce overall treatment time. In addition, a shorter schedule permits more efficient use of RT resources. To determine if APBI could replace WBI as standard of care for selected women with early breast cancer treated with BCT, it is necessary to demonstrate its technical feasibility and equivalence of outcomes compared to WBI. This study investigates the feasibility, toxicity, cosmetic outcome, local control and QoL of women with early breast cancer treated with APBI using a novel technique. It uses advanced 3-dimensional RT planning and multiple fields shaped to conform to the target volume (tumour bed) and spare the normal organs. It is more likely than the other modalities to be adopted as the preferred APBI technique in Australia because it uses equipments readily available in most RT centres and being non-invasive, is likely to be preferred by patients. However, its feasibility in multiple Australian centres with varying RT equipments is unclear. Given the current high level of international interest, it is timely to conduct this feasibility study in preparation for large scale research to determine if APBI may replace WBI in BCT.Read moreRead less