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.
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
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
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
Prevention Of Late Breast Cancer (BC) Events In Postmenopausal Women With Endocrine Responsive BC.
Funder
National Health and Medical Research Council
Funding Amount
$4,687,599.00
Summary
This proposal is from Australia's national breast cancer (BC) trials group, the ANZ BCTG, for a new phase III, multi-centre clinical trial evaluating whether much later endocrine therapy with an aromatase inhibitor can prevent BC recurrence in postmenopausal women who have: had hormone sensitive BC at least 6 years ago; were treated by Tamoxifen more than 1 year ago; and, are currently disease free. Subjects will randomly receive letrozole or placebo as a daily tablet for five years.
Clinical Trial Of Adjuvant Docetaxel And Doxorubicin For Node Positive Breast Cancer.
Funder
National Health and Medical Research Council
Funding Amount
$185,135.00
Summary
This project is investigating the optimal use of docetaxel and doxorubicin in the treatment of women with breast cancer and involved lymph nodes (N+). Every year 3000 women in Australia, and over 400,000 worldwide are newly diagnosed with N+ breast cancer. Using available treatments more than 60% of these (5 per day in Australia, 4,500 each week worldwide) will die from breast cancer. The efficacy of adjuvant chemotherapy in early breast cancer is well established by the international overview c ....This project is investigating the optimal use of docetaxel and doxorubicin in the treatment of women with breast cancer and involved lymph nodes (N+). Every year 3000 women in Australia, and over 400,000 worldwide are newly diagnosed with N+ breast cancer. Using available treatments more than 60% of these (5 per day in Australia, 4,500 each week worldwide) will die from breast cancer. The efficacy of adjuvant chemotherapy in early breast cancer is well established by the international overview conducted by the Early Breast Cancer Trialist's Collaborative Group (EBCTCG). They have demonstrated the efficacy of adjuvant chemotherapy on reducing mortality and recurrence rates, but current regimens are far from optimal. Docetaxel (Taxotere), a new agent, has effectiveness and manageable side effects in the treatment of advanced breast cancer patients, and can plausibly improve outcomes for patients with early N+ breast cancer by optimal integration into current adjuvant chemotherapy regimens. This clinical trial is designed to compare whether it is advantageous to use docetaxel and-or doxorubicin in combination or sequentially with other currently available chemotherapy drugs.Read moreRead less
Patient Preferences For Adjuvant Chemotherapy In Early Breast Cancer: What Makes It Worthwhile?
Funder
National Health and Medical Research Council
Funding Amount
$69,420.00
Summary
Adjuvant chemotherapy, used in addition to surgery and radiation, improves recurrence and survival rates in women with early breast cancer. These gains must be balanced against the side effects and inconvenience of chemotherapy including hair loss, nausea, tiredness and risk of infection. This study will determine the gains considered necessary to make modern adjuvant chemotherapy for early breast cancer worthwhile by asking women who have had such treatment. It will determine factors that might ....Adjuvant chemotherapy, used in addition to surgery and radiation, improves recurrence and survival rates in women with early breast cancer. These gains must be balanced against the side effects and inconvenience of chemotherapy including hair loss, nausea, tiredness and risk of infection. This study will determine the gains considered necessary to make modern adjuvant chemotherapy for early breast cancer worthwhile by asking women who have had such treatment. It will determine factors that might influence the gain considered necessary, such as the kind of treatment, the severity of the side effects experienced, social and other factors. Three hundred women who have had modern adjuvant chemotherapy in an ongoing international clinical trial will be recruited and interviewed. The interviews are standardised, scripted and administered by trained researchers to avoid influencing the subjects. Diagrams and props are used to make the questions clearer. Evaluation of these aids is an additional aspect of the project. This information will be invaluable for women and clinicians considering this potentially curative treatment over the next 15 years. The study will also provide new knowledge on how best to provide information about the benefits of treatment. This can then be applied to discussions about treatment in routine clinical practice. The methods are suitable for a wide range of questions in other diseases and settings. The project will be extended to develop the materials for other questions in breast cancer and other settings.Read moreRead less
Optimising Regulatory T Cell Depletion In Combination With Chemotherapy For Enhanced Anti-tumour Immunity
Funder
National Health and Medical Research Council
Funding Amount
$264,816.00
Summary
The drug cyclophosphamide helps the immune system attack cancer by decreasing the number of immune cells that suppress an immune response to cancer ('Regulatory T cells'). This project combines standard chemotherapy with the drug cyclophosphamide in people with mesothelioma and lung cancer. The aim of the project is to find the dose of cyclophosphamide that maximally decreases Regulatory T cells in each patient, and determine the effect of this on anti-tumour immunity and response to treatment.
A Randomised Trial Of Preoperative Radiotherapy For Stage T3 Adenocarcinoma Of Rectum
Funder
National Health and Medical Research Council
Funding Amount
$521,220.00
Summary
The most appropriate management of locally advanced rectal cancer is controversial as evident by various treatment options available and used. It remains unclear whether pre-operative radiotherapy, and if so what form of therapy, is required for this group of patients. The first aim of this trial is to see whether a long course of radiotherapy with chemotherapy is superior to a short course of radiotherapy. The second aim is to see whether the advantage of pre-operative radiotherapy remains with ....The most appropriate management of locally advanced rectal cancer is controversial as evident by various treatment options available and used. It remains unclear whether pre-operative radiotherapy, and if so what form of therapy, is required for this group of patients. The first aim of this trial is to see whether a long course of radiotherapy with chemotherapy is superior to a short course of radiotherapy. The second aim is to see whether the advantage of pre-operative radiotherapy remains with modern surgical technique. Colorectal cancer is the commonest cancer in Australia and local recurrence leads to severe morbidity with no effective treatment for permanent control. It is important, therefore, to establish treatment regimens that will minimize the risk of local recurrence and it will be significant if this trial can establish that pre-operative radiotherapy can achieve this with minimal toxicity. The quality of life associated with each of the three arms of the trial has not been adequately addressed and will be studied here. The result of this trial will influence designs of future trials if one or other of the pre-operative regimens is shown to be effective. The two regimens, Short Course and Long Course , represent opposing philosophies: minimize the overall treatment time (2 weeks from start of radiotherapy to surgery) to avoid accelerated repopulation versus give more intensive therapy and utilise the sensitising effect from 5-FU on radiotherapy to obtain greater tumour cell kill probability. If one regimen proves more effective than the other, the design of future trials and the way of thinking about the biology will be influenced. There may be implications for the cost of treatment of this disease: Long Course is much about five times more expensive to deliver than Short Ccourse.Read moreRead less