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
POSNOC (Positive Sentinel Node – A Randomised Trial Of Adjuvant Therapy Alone Versus Adjuvant Therapy Plus Clearance Or Axillary Radiotherapy)
Funder
National Health and Medical Research Council
Funding Amount
$1,223,428.00
Summary
POSNOC (POsitive Sentinel NOde – adjuvant therapy alone versus adjuvant therapy plus Clearance or axillary radiotherapy) will address the key unresolved challenge in breast cancer surgery. A controversial US trial, ACOSOG Z0011, indicates that many breast cancer patients with limited disease in the sentinel node can safely avoid further nodal surgery. This would be a major advance, but there is widespread doubt that the results are broadly applicable. POSNOC will clarify this key issue.
Micro-elastography - A New Tool For Microscopic Intraoperative Tumour Margin Assessment In Breast Cancer
Funder
National Health and Medical Research Council
Funding Amount
$195,956.00
Summary
In breast cancer surgery, it is vital to completely remove the entire tumour. Unfortunately, in 30% of breast-conserving surgeries, re-excision is required because microscopic analysis after the surgery indicated some tumour had been missed. This has traumatic consequences for the patient and places a huge economic burden on the healthcare system. Using micro-elastography, we will enable the surgeon to detect small regions of tumour during the initial surgery. This probe may significantly reduce ....In breast cancer surgery, it is vital to completely remove the entire tumour. Unfortunately, in 30% of breast-conserving surgeries, re-excision is required because microscopic analysis after the surgery indicated some tumour had been missed. This has traumatic consequences for the patient and places a huge economic burden on the healthcare system. Using micro-elastography, we will enable the surgeon to detect small regions of tumour during the initial surgery. This probe may significantly reduce the number of additional surgeries required.Read moreRead less
SNAC2: A Randomised Trial Of Extending Sentinel Node Based Management To Women With Larger Or Multifocal Breast Cancers
Funder
National Health and Medical Research Council
Funding Amount
$1,266,430.00
Summary
SNAC2 extends the work begun in SNAC1, which recruited 1,088 women over 4 years. SNAC1 will determine if sentinel node biopsy causes less arm problems than axillary clearance. The goal of SNAC2 is to establish the risk of local recurrence and long term safety of sentinel node biopsy, especially for women with larger or multiple tumours. SNAC2 is needed to determine whether the smaller operation gives cure rates as good as axillary clearance. If it does, then it will become standard practice.
SNAC1: A Randomised Trial Of Sentinel Node Based Management Versus Axillary Clearance For Women With Small Breast Cancers
Funder
National Health and Medical Research Council
Funding Amount
$366,663.00
Summary
SNAC1 will determine if sentinel node based management (a smaller operation removing a few lymph nodes) results in better quality of life and equivalent cure rates after 10 years follow-up compared with routine axillary clearance (a larger operation removing many lymph nodes) in over 1000 women with early breast cancer recruited to this large scale randomized trial from 2001 to 2005
Development Of Targeted Therapies To Reverse The Effects Of Ageing And Disease On Wound Healing And Tissue Generation
Funder
National Health and Medical Research Council
Funding Amount
$391,228.00
Summary
Despite success with the production of new tissues and organs in laboratory animals, tissue engineering in humans remains elusive. Emerging evidence suggests that ageing and diseases such as diabetes can adversely affect human stem cell regenerative capacity. Characterizing the effects of ageing and disease on stem cells during tissue generation is the first step in reversing these effects, paving the way for the production of new tissues and organs for use in human clinical trials.
SNAC1:A Randomised Trial Of Sentinel Node Based Management Versus Axillary Clearance For Women With Small Breast Cancers
Funder
National Health and Medical Research Council
Funding Amount
$1,338,436.00
Summary
SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary clearance and 2)sentinel node biopsy. Axillary clearance involves removal of most lymph nodes in the armpit. In sentinel node biopsy only a few lymph nodes most closely related to the breast cancer are removed. The trial will determine if sentinel node biopsy reduces lymphoedema and gives equivalent cure rates. If it does, then it should become standard practice.
SNAC1:A Randomised Trial Of Sentinel Node Based Management Versus Axillary Clearance For Women With Small Breast Cancers
Funder
National Health and Medical Research Council
Funding Amount
$240,187.00
Summary
Over 13,000 ANZ women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spead to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary cle ....Over 13,000 ANZ women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spead to glands in the armpit (axillary lymph nodes). Knowing whether the cancer has spread to the axillary lymph nodes helps determine prognosis and plan treatment. Surgical removal is the most reliable way to assess the axillary lymph nodes. SNAC1 compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) axillary clearance and 2) sentinel node biopsy. Axillary clearance involves removal of most lymph nodes in the armpit. In sentinel node biopsy only a few lymph nodes most closely related to the breast cancer are removed. Axillary clearance is the current standard operation. However, it is associated with risks including infection, pain, stiffness, numbness and lymphoedema (arm swelling). Lymphoedema may occur in 5-50% of women treated for breast cancer and can cause major suffering and disability. In many women their breast cancer has not spread to the lymph nodes, and axillary clearance is unnecessary. Recent studies suggest sentinel node biopsy may provide as much information as axillary clearance. Scans and dye are used to help locate the sentinel nodes. Minimising the amount of surgery to the armpit should reduce the side effects. However, the long term safety and effectiveness of removing only a few nodes is unknown. The trial will determine if sentinel node biopsy reduces lymohoedema and gives equivalent cure rates. If it does, then it should become standard practice. The study complements comparable studies being done in US, UK and Europe by providing unique information about arm symptoms and quality of life. SNAC1 recruited 1,088 women in 4 years. This application is for the work needed to report on outcomes after all women have been followed for 5 years.Read moreRead less
Development Of An Intra-Operative Tool For Tumour Margin Assessment During Surgery
Funder
National Health and Medical Research Council
Funding Amount
$599,472.00
Summary
The objective of this study is to develop and evaluate a surgical probe that uses novel terahertz technology to guide surgical excision. As an example, approximately 3,000 breast cancer patients per year require a second surgical procedure because of tumour identified close to the edge of tissue removed during surgery. There is a clinical need for an accurate, real-time and non-destructive technique to assess tumour margins during surgery. This tool could also be used for any surgery that requir ....The objective of this study is to develop and evaluate a surgical probe that uses novel terahertz technology to guide surgical excision. As an example, approximately 3,000 breast cancer patients per year require a second surgical procedure because of tumour identified close to the edge of tissue removed during surgery. There is a clinical need for an accurate, real-time and non-destructive technique to assess tumour margins during surgery. This tool could also be used for any surgery that requires preservation of normal tissue.Read moreRead less
Optimal Scheduling Of Cancer Surgery And Adjuvant Therapy
Funder
National Health and Medical Research Council
Funding Amount
$667,008.00
Summary
Cancer surgery is the most effective single modality for curing patients. Unfortunately, 50% of patients will relapse after surgery due to metastases and require further therapy. Immunotherapies such as Ipilimumab/Nivolumab have been revolutionary in causing long term tumour regression and potential cures in advanced cancers. We have preliminary data showing immunotherapies given before surgery is more effective in preventing metastases and we aim to understand the reason for its effectiveness.