A clinical trial is a research study conducted with patients who have been diagnosed with a cancer (or other major illness) and generally involves testing of new treatments or finding ways to improve existing treatments. Clinical trials are conducted all over the world in most large hospitals in an attempt to improve treatment for many different diseases. Such trials help us find out if a promising new treatment is safe and effective, as well as giving us a better understanding of the current standard treatment, in the hope of improving the side effects experienced by a lot of patients.
Many of the advances in cancer cure rates today have been achieved by slow, steady step wise improvements in treatments over some years. This has been achieved by hundreds of thousands of patients entering trials all over the world.
All the ethical and legal codes that apply to ordinary medical practice are very carefully followed in clinical trials. For instance, the scientific committee and the general membership of TROG, regularly review the trial design and progress. All TROG trials are reviewed by the ethics committees of the participating hospitals. The ethics committees is made up of doctors, scientists, clergy and lay people, who must approve the start and continuation of all clinical trials at their hospital. If this committee felt that a trial was poorly designed, dangerous or unethical, it would refuse TROG or any other group permission to perform this trial on patients.
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further general information on clinical trials.
Title
A paired double blind randomised comparison of Cavilon Durable Barrier Cream (CDBC) to 10% Glycerine (“Sorbolene”) Cream in the prophylactic management of post-mastectomy irradiation skin care
Summary
This national randomised trial will compare 2 kinds of cream to determine which is best at preventing skin problems for women having radiotherapy to their chest after breast cancer surgery.
Contact
Dr Peter Graham
Cancer Care Centre
St George Hospital
Kogarah NSW 2217
Fax: +612 9350 3958
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Title
A randomised phase III study in advanced oesophageal carcinoma to compare dysphagia in patients treated with radiotherapy versus chemo-radiotherapy.
Summary
People with cancer of the oesophagus (gullet) often have trouble swallowing. Radiotherapy can help improve this problem. Using chemotherapy together with radiotherapy may work better but has more side effects. This trial will determine if it is better to use radiotherapy by itself or together with chemotherapy
Contact
Dr Michael Penniment
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Fax: +61 8 8222 2016
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Title
Multicentre Phase III Study Comparing Radical Synchronous Chemo-Radiation vs Radical Radiation Alone in the Definitive Management of Muscle Invasive TCC of the Urinary Bladder Following Maximal Trans-Urethral Resection
Summary
Radiation and chemotherapy both work in people with muscle-invasive bladder cancer. This study will determine if giving them together improves the results for people with this disease that seems to be confined to the bladder, but who are felt to be suitable candidates for bladder preserving treatment.
Contact
Dr Kumar Gogna
Queensland Radium Institute, Mater Centre
Raymond Terrace
South Brisbane QLD 4101
Fax: +61 7 3840 3399
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Title
Prospective study to determine the relationships between survival and FIGO stage, tumour volume and corpus invasion in cervical cancer
Summary
TBC
Contact
Assoc Prof Kailash Narayan Narayan
Peter MacCallum Cancer Centre
St Andrews Place, East Melbourne
Fax: +61 3 9656 1424
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Title
A randomised phase II study of two regimens of palliative chemoradiation therapy in the management of locally advanced non-small cell lung cancer
Summary
Using radiotherapy and chemotherapy together works better in locally advanced lung cancer than using either treatment alone but has worse side effects. Many people are not fit enough to have these treatments given in the standard way. This study will test the feasibility and activity of two gentler ways of combining them.
Contact
Associate Professor Bryan Burmeister
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Fax: +61 7 3240 2670
Dr Michael Michael
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Fax: +61 3 9565 1424
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Title
A randomised multicentre trial of involved field radiotherapy versus involved field radiotherapy plus chemotherapy for stage I - II low grade follicular lymphoma
Summary
Stage I-II low-grade follicular lymphoma is a cancer of the lymph glands that responds well to local radiation therapy but often comes back (recurs) in other parts of the body. This trial will determine if adding chemotherapy to radiation reduces the risk of this kind of lymphoma coming back.
Contact
Assoc Prof Michael MacManus
Peter MacCallum Cancer Centre
St Andrews Place, East Melbourne
Fax: +61 3 9656 1424
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Title
A prospective, non-randomised study of chemotherapy and radiotherapy for Osteolymphoma (OL)
Summary
Osteolymphoma is a cancer of the bone marrow that responds well to radiation therapy and chemotherapy but may come back in other parts of the body. This trial will determine the results of combining radiation therapy and chemotherapy in a standardised way.
Contact
Dr David Christie
East Coast Cancer Centre
Inland Drive, Tugun QLD 4224
Fax: +61 7 5598 0377
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Title
An ALLG/TROG prospective multicentre study of involved-field radiotherapy with transplantation for patients with Hodgkin’s disease and non-Hodgkin’s lymphoma.
Summary
TBC
Contact
Dr Andrew Wirth
Peter MacCallum Cancer Centre
St Andrews Place, East Melbourne
Tel: +61 3 9656 1111 Fax: +61 3 9656 1424
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Title
A prospective single arm trial of involved field radiotherapy alone for stage I-II low grade non-gastric marginal zone lymphoma
Summary
Aims of the study :
- To conduct the first multicentre prospective trial of radiotherapy (RT) in stage I-II Marginal Zone Lymphoma (MZL)
- To prospectively identify causal factors for MZL, including infection and inflammatory disease
This study will be the first large trial of any form of therapy for stage I-II, non-gastric marginal zone lymphoma. There is an enormous deficit in the literature with respect to this fascinating but relatively recently-recognised entity. MZL is commonly associated with underlying inflammatory or infective disorders and it is clear, at least in some cases with infection by organisms called Helicobacter Pylori and Chlamydia Psitacci, that the inflammatory condition can actually cause the lymphoma. The role of H. Pylori infection has not been well studied in non gastric MZL in large prospective studies, despite anecdotal reports of regression of non gastric MZL after H Pylori eradication. There have been reports of responses to doxycycline (antibacterial) therapy in patients with evidence of chlamydial infection (C. Psitacci) in MZL of the tissues around the eye. This association has not been well studied in any large prospective study and no long-term data for doxycycline therapy exist. Management of stage I-II MZL is variable and often ad-hoc in Australia, despite significant retrospective evidence to support radiotherapy (RT) as the curative treatment modality of choice. In this TROG/ALLG joint study, 100 patients will be recruited over 5 years. All patients will undergo breath tests or endoscopy to detect H. Pylori infection. Ocular MZL specimens will be sent to Italy to test for C. Psitacci. Patients will receive highly standardised treatment with RT. This study will definitively document the efficacy and safety of RT in stage I and II non-gastric MZL and will include patients with stage IV disease limited to paired-organs, as this disease shows a tendency to home in exclusively on particular organs, such as salivary glands.
Contact
Assoc Prof Michael MacManus
Peter MacCallum Cancer Centre
St Andrews Place, East Melbourne
Tel: +61 3 9656 1111
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Title
A Randomised Clinical Trial of Surgery versus Surgery plus Adjuvant Radiotherapy for Regional Control in Patients with Completely Resected Macroscopic Nodal Metastatic Melanoma
Summary
Surgery is the standard treatment for melanoma that has spread to nearby lymph glands, but it sometimes recurs despite surgery. Radiotherapy given soon after surgery may reduce the risk of the melanoma coming back, but may also cause side effects. This national randomised trial will determine the benefits and side effects of adding radiotherapy after surgery.
Contact
Associate Professor Bryan Burmeister
Princess Alexandra Hospital
Fax: +61 7 3240 2670
Professor John Thompson
Sydney Melanoma Unit
Missenden Rd, Camperdown, NSW, 2050
Fax: +61 2 9550 6316
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Title
Post-Operative concurrent chemo-radiotherapy versus post-operative radiotherapy in high-risk cutaneous squamous cell carcinoma of the head and neck
Summary
Two in every 3 Australians will develop a skin cancer over their lifetime. While the majority are easily cured with surgery there is a proportion that become advanced or have spread to lymph nodes. The cure rate for these cancers can be as low as 50% even after surgery and post-operative radiotherapy. There is evidence in other cancer that the combination of post-operative radiotherapy and chemotherapy, given at the same time, improves cure rates. To date, there is no evidence that such a benefit exists in advanced skin cancer. Carboplatin has been shown to be safe and effective in other cancer sites. This trial is a randomised trial comparing standard post-operative radiotherapy (delivered over 6 weeks, 5 days/week) with standard radiotherapy and weekly Carboplatin (given one day/week during the radiotherapy as a 30 minute intravenous infusion). This trial is assessing whether the addition of chemotherapy to post-operative radiotherapy improves cure rates. If the addition of chemotherapy is shown to be of benefit and safe, it is likely the results will be rapidly translated into clinical practise.
Contact
Dr Sandro V Porceddu
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Tel: +61 7 3240 2111 Fax: +61 7 3240 6127
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Title
A randomised trial investigating the effect on biochemical PSA control and survival of different durations of adjuvant androgen deprivation in association with definitive radiation treatment for localised carcinoma of the prostate (RADAR)
Summary
Six months of hormone treatment improves the results of radiotherapy for men with early prostate cancer. This trial will determine if adding another 12 months of hormone treatment after radiotherapy is even better. Bones are often affected by prostate cancer and can also be damaged by prolonged hormone treatment. Bisphosphonates are drugs that make bones stronger and may also stop secondary cancer from developing. This trial will therefore also determine if treatment with a bisphosphonate can help prevent these bone problems.
Contact
Jean Ball
Fax: (02) 4921 1465
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Title
A Collaborative randomised phase III trial: The timing of intervention with androgen deprivation in prostate cancer patients with a rising PSA
Summary
Men with incurable prostate cancer often live for many years without any symptoms. Hormone treatment usually controls the disease for several years but has side effects. This ANZ randomised trial will determine if it is better to start hormone treatment straight away or to wait and start hormone treatment only after the prostate cancer begins to cause problems.
Contact
Deborah Howell
Fax: (03) 9635-5410
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Title
A Phase III International Randomised Trial Of Single Versus Multiple Fractions For Re-Irradiation Of Painful Bone Metastases
Summary
Radiotherapy is an effective treatment for people with cancer that has spread to their bones and is causing problems. Sometimes, a second course of radiation is required. This international randomised trial will determine if it is better for a second course of radiation to be done as one large treatment, or as several smaller treatments.
Contact
Dr Daniel Roos
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Fax: +61 8 8222 2016
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Title
Primary chemotherapy with Temozolomide vs radiotherapy in patients with low grade gliomas after stratification for genetic 1p loss: a phase III study. (EORTC)
Summary
TBA
Contact
Dr Gail Ryan
Division of Radiation Oncology
Peter MacCallum Cancer Centre
Fax: +61 3 9656 1424
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