A Randomised Trial Of Adjuvant Chemotherapies In Resectable Pancreatic Cancer: ESPAC-3
Funder
National Health and Medical Research Council
Funding Amount
$430,500.00
Summary
Over 1,650 Australians are diagnosed with pancreatic cancer each year. In most cases, surgery will remove the tumour but it is possible that the cancer will return as a result of undetectable disease (micrometastases). The cancer will return and be incurable in the majority of patients. More than 1600 Australians die of the disease every year. This study compares the impact of adding chemotherapy to surgery alone (the current standard of care). The study will also compare the effectiveness of tw ....Over 1,650 Australians are diagnosed with pancreatic cancer each year. In most cases, surgery will remove the tumour but it is possible that the cancer will return as a result of undetectable disease (micrometastases). The cancer will return and be incurable in the majority of patients. More than 1600 Australians die of the disease every year. This study compares the impact of adding chemotherapy to surgery alone (the current standard of care). The study will also compare the effectiveness of two different types of chemotherapy. Surgical resection of a pancreas tumour is the current standard of care for this disease. It is possible that people treated with chemotherapy after their tumour has been surgically removed may live longer before their disease returns and may liver longer overall. This has been shown to be true in other in cancers; eg. breast and bowel. The side effects of chemotherapy are important and can be severe in some people. Recent studies in advanced pancreatic cancer have suggested that the new drug gemcitabine may be more effective than other drugs. For this reason, the trial compares the outcomes in people treated with gemcitabine to those treated with an older drug 5FU, which has been shown to improve survival in an earlier study by a European group. This trial will determine if chemotherapy in addition to surgery increases the length of time before the disease comes back and survival. If it does, it should become standard practice. This study is an important international initiative that will provide unique information about effectiveness of these treatments and their impact on quality of life from the patient's perspective. This study and the previous European study are the largest of their type ever done. 900 people will take part. This study is being conducted in Australia by the Australasian Gastro-Intestinal Trials in collaboration with the Australian Hepatobilary Association and the NHMRC Clinical Trials Centre.Read moreRead less
Sentinel Node Biopsy Versus Axillary Clearance In Early Breast Cancer: The SNAC Trial
Funder
National Health and Medical Research Council
Funding Amount
$1,257,525.00
Summary
Over 10,000 Australian women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spread 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. This study compares two operations for assessing cancer spread to the lymph nodes in women with early breast cancer: 1) ....Over 10,000 Australian women are diagnosed with breast cancer each year. Most need surgery to remove the cancer and determine if it has spread 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. This study 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 symptoms and disabilities. In many women the 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. This trial will determine if sentinel node biopsy reduces lymphoedema and gives equivalent cure rates. If it does, then it should become standard practice. The study compliments comparable studies being done in US, UK and Europe by providing unique information about symptoms and quality of life from the women's perspective. One thousand Australian women will take part. The is study is being conducted by Australian breast surgeons under the auspices of the Royal Australasian College of Surgeons and the NHMRC Clinical Trials Centre.Read moreRead less
Value Of Androgen Deprivation And Bisphosphonate Therapy In Patients Treated By Radiotherapy For Limited Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$1,757,375.00
Summary
Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation'[AD] therapy) can produce clinically important shrinkage of prostate cancer. Each year approximately 4000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Results from recent trials, including a large trial run in Au ....Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation'[AD] therapy) can produce clinically important shrinkage of prostate cancer. Each year approximately 4000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Results from recent trials, including a large trial run in Australia and New Zealand by the Trans-Tasman Radiation Oncology Group (TROG) between 1996 and 2000, suggest that 6 months AD will benefit many of these men if administered in conjunction with radiotherapy.The aim of this project is to run a further trial to find out whether 12 months of AD, after radiotherapy will prevent the need for further treatment and prolong more lives than only 6 months AD. Bisphosphonate treatment also offers important benefits to prostate cancer patients because it can increase bony stregth by increasing its density and can also arrest cancerous growth in bones. A further aim of the trial therefore is to determine whether 18 months of bisphosphonate therapy (BP) will prevent bone loss (osteoporosis) caused by AD, and also further reduce the risk of secondary bone cancer developing. This trial will involve recruitment of 1000 men across Australia and New Zealand over a 5 year period. When complete the trial will determine whether further treatment can be delayed and life prolonged in up to half of all men in whom treatment presently fails. This grant will support collection of patient data and the necessary quality checks to ensure that reliable conclusions can be drawn.Read moreRead less
Radiotherapy Vs Chemotherapy For Low-grade Gliomas Stratified For Genetic 1p Loss: Efficacy And Quality Of Life Benefits
Funder
National Health and Medical Research Council
Funding Amount
$410,316.00
Summary
Low-grade glioma is an uncommon malignant brain tumour. Surgery, radiotherapy and chemotherapy delay growth of this tumour, but cure is uncommon. Currently the goal of treatment is to control tumour growth for as long as possible whilst maintaining quality of life. This study compares treatment with radiotherapy with a new form of chemotherapy to see which treatment controls tumour growth most effectively, which produces the least side effects and which results in the better quality of life.
Improving The Management Of Nausea In Advanced Cancer: Pragmatic Tool For Assessing& Treating Nausea In Clincial Practi
Funder
National Health and Medical Research Council
Funding Amount
$100,000.00
Summary
Nausea and vomiting are common problems in-patients with advanced cancer and they are under-treated. The investigators will develop evidence-based tools to assist non-specialist clinicians in the assessment and treatment of nausea in advanced cancer. They will also develop an educational intervention to train health professionals to use these tools and pilot a randomised trial designed to evaluate the package in NSW and WA.
Randomised Trials Of Adjuvant Cytotoxic & Endocrine Therapy For Early N+ And N- Breast Cancer
Funder
National Health and Medical Research Council
Funding Amount
$510,509.00
Summary
This application covers 4 adjuvant early breast cancer trials currently part of the Australian New Zealand Breast Cancer Trials Group's national research programme. These trials are international collaborations involving the International Breast Cancer Study Group (IBCSG). Two of the studies concern pre, peri and post-menopausal women with early breast cancer and no involved lymph glands (IBCSG 8 and 9), and two concern pre, peri and post-menopausal women with early breast cancer and involved ly ....This application covers 4 adjuvant early breast cancer trials currently part of the Australian New Zealand Breast Cancer Trials Group's national research programme. These trials are international collaborations involving the International Breast Cancer Study Group (IBCSG). Two of the studies concern pre, peri and post-menopausal women with early breast cancer and no involved lymph glands (IBCSG 8 and 9), and two concern pre, peri and post-menopausal women with early breast cancer and involved lymph glands (IBCSG 13 and 14). In the absence of a definitive cure, the largest gains will come from optimal use of current therapies and new therapies to improve survival, and where possible, to reduce morbidity without the loss of efficacy. These four trials can realistically expect to produce important gains with potential benefit to the many women who are diagnosed with early breast cancer each year. The active accrual period for these studies is complete but all patients are currently on life long follow-up. Patients accrued to trial 8 have a clinical assessment 3 monthly to 2 years, 6 monthly to 5 years, and then annually. For trials 9, 13 and 14 women have a clinical assessment 3 monthly during year 1, 6 monthly for year 2 and then annually.Read moreRead less
Optimal Duration Of Neoadjuvant Androgen Deprivation Therapy In Localised Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$275,000.00
Summary
Each year approximately 8000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation' [AD] therapy) can produce shrinkage of prostate cancer. In fact AD has caused temporary but valued relief to millions of men with cancer ....Each year approximately 8000 men in Australia and New Zealand develop prostate cancer which has not spread widely and which is amenable to attempted cure by surgery or radiation. Prostate cancer depends for its growth on the male hormone, testosterone, which circulates in the blood. As a result treatment which reduces testosterone level ('androgen deprivation' [AD] therapy) can produce shrinkage of prostate cancer. In fact AD has caused temporary but valued relief to millions of men with cancer of the prostate that has spread throughout the body for the last five decades, worldwide. It remains uncertain however whether AD administered before surgery or radiation will benefit any of the 8000 men each year who develop localised cancer by shrinking the cancer first. In 1996 a trial involving 800 men across Australia and New Zealand commenced under the auspices of the Trans-Tasman Radiation Oncology Group (TROG) to answer the questions: 1 - Does either 3 or 6 months AD prior to radiotherapy reduce the chances of recurrence of the cancer after radiotherapy? 2 - Does such therapy reduce the volume of tissue requiring radiotherapy and hence the chances of long term side effects after radiotherapy? This grant will support collection of follow-up information from the trial and hence answers to the questions asked.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
$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