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Clinical Trials in Progress

Contact details:

Trials designed and implemented locally:

Description:
Prospective study of radioactive seed implantation of prostate in Australasia.

Women who are diagnosed with a small operable cancer in their breast generally go on to have surgery to remove the cancer very soon after diagnosis. Surgery is then traditionally followed by radiotherapy. The combination of surgery and radiotherapy offers an equivalent rate of survival as having a mastectomy.

The standard form of radiotherapy for patients who have had a small breast cancer removed is delivered externally (through the skin), and is given daily (Mon-Fri) for 5-7 weeks.

Intrabeam

Sir Charles Gairdner Hospital (along with various sites around the world) is currently trialing the use of a singe dose of intra-operative radiotherapy for women with early, low risk of local recurrence breast cancer, in place of the 5-7 weeks of external radiotherapy.

The Hospital is using an intra-operative radiotherapy device called the “Intrabeam”. The Intrabeam is used in theatre either during the operation when the cancer is being removed, or during a separate delayed operation a few weeks later.

Intra-operative radiotherapy is being trialed because of the potential advantages of having the treatment targeted right into the breast tissue from where the tumour was taken from (this is the tissue where the cancer is most likely to return). It is thought that because it does not have to go through the skin, it may lead to fewer skin-related side effects. More importantly however, using intra-operative radiotherapy may lead to a decreased risk of local recurrence because of its direct approach to the tissue that needs it the most.

Intra-operative radiotherapy utilising the Intrabeam Device is not yet considered a standard treatment at Sir Charles Gairdner Hospital. Patients are therefore only able to undergo treatment with the device if they are registered on one of the two ethically approved clinical trials currently being conducted by the Department of Radiation Oncology (in close collaboration with the Breast Assessment Centre) at Sir Charles Gairdner Hospital.

Eligible patients are identified by their surgeon and referred to the Department of Radiation Oncology, prior to actually having had their surgery to remove the cancer.

As with most clinical trials, strict eligibility criteria need to be met in order for patients to be identified as suitable and subsequently registered onto the trial.

Sir Charles Gairdner Hospital, along with sites in the USA, Middle East, UK, Germany and Italy will soon join the International Randomised Clinical Trial that will compare a singe dose of intra-operative radiotherapy with conventional external beam radiotherapy. Patients registered on this trial will have a 50% chance of receiving intra-operative radiotherapy and a 50% chance of receiving conventional external beam radiotherapy. Women who are found to have a high risk of local breast cancer recurrence but are randomised to the intra-operative radiotherapy arm will also go on to receive 5 weeks of external radiotherapy to the whole breast. This trial has therefore been carefully designed to ensure all patients receive the full extent of treatment that they need.

If intra-operative radiotherapy is found to offer either equivalent or better control of local recurrence when compared to conventional radiotherapy, then suitable women may be able to avoid the 5-7 weeks of daily external beam treatment by having a single dose of intra-operative radiotherapy instead. The trial results are not expected to be available for at least another 3-5 years.

Sir Charles Gairdner Hospital also runs another intra-operative radiotherapy study which is available for patients who may greatly benefit from intra-operative radiotherapy but are not eligible to be considered for the International Randomised Trial. Patients in this trial are not randomised to receive a particular treatment, but do have intra-operative radiotherapy as a component of their treatment for their breast cancer.

Trans-Tasman Radiation Oncology Trials

03.05 A Phase III Study of Regional Radiation Therapy in Early Breast Cancer.

Description:
Patients stratified by:

Number of positive nodes (9, 1-3, >3)
Type of chemotherapy (anthracycline containing, other, or none)
Hormonal therapy (yes, no)
Number of axillary nodes removed (<10*, >10)

Centre

Patient randomised to receive one of the following treatments to a planned sample size of 1822.

Arm 1: Standard Breast Radiation (Control)
Arm 2: Breast Radiation plus Regional Radiation (Experimental)

Radiotherapy should be administered following completion of chemotherapy and must be started within 8 weeks of the last dose of IV chemotherapy or within 16 weeks of last surgical procedure on the breast for patients receiving only hormonal treatment. For those patients receiving cyclophosphamide methotrexate 5-flurourocil (CMF), radiation therapy may be given concurrently with chemotherapy according to local practice guidelines.

03.04 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.

Description:
Randomised to one of four arms:
Arm A: (STAD) LH-RH analogue for 5 months prior to and during first month of RT Treatment (total of 6 months). No bisphosphonate therapy.
Arm B: (STAD) LH-RH analogue for 5 months prior to and during first month of radiation treatment (total of 6 months).
Bisphosphonate therapy – Zometa 4mg IV 3-monthly x 18 months.
Arm C: (ITAD) LH-RH analogue (as STAD) but continued for further 12 months (total 18 months). No bisphosphonate therapy.
Arm D: (ITAD) LH-RH analogue as for STAD arm, but continued for further 12 months (total 18 months).
Bisphosphonate therapy – Zometa 4mg IV 3-monthly x 18 months.

03.02 A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

Description:
Surgery to completely resect and histologically prove adenocarcinoma of stomach or gastro-oesophageal junction. Treatment will start within 7 weeks post surgery. Weeks 1-3 chemotherapy. Weeks 5-9 RT/concomitant chemotherapy. Weeks 14-16 chemotherapy. Weeks 17-19 chemotherapy.

DRAFT A Randomised Trial for Surgery Plus Whole Brain Radiotherapy (WBRT) versus Radiosurgery Plus WBRT for Solitary Brain Metastases.

Description:
Patients will be stratified, 1) Recursive Partitioning Analysis (RPA) class 1 vs 2 vs 3 and
2) centre
Patients randomised to receive surgery plus WBRT or to Radiosurgery plus WBRT.

02.01 A Randomised Clinical Trial of Surgery Versus Surgery Plus Adjuvant Radiotherapy for Regional Control in Patients with Completely Resected Macroscopic Nodal Metastatic Melanoma.

Description:
Patients randomised between the two arms, radiotherapy and no radiotherapy. Nodal basin sites are parotid or neck; axilla; groin. Patients randomised to receive post-operative adjuvant radiotherapy will receive 48Gy in 20 fractions over 30 days. Radiotherapy is required to commence no later than 12 weeks following lymphadenectomy

02.03 A Randomised Phase III Trial of Radical Chemotherapy/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder

Description:
Patients will be randomised to receive either radiation alone or chemotherapy/radiation. Radiotherapy will be given over 5 sessions per week for 6 1/2 or 7 weeks.
Patients randomised to chemotherapy/radiation will receive Cisplatin at a weekly dose of 35mg/m2. Chemotherapy given at beginning of each week (Mon/Tues) of treatment on same day of the week on each occasion throughout the course of treatment. No Cisplatin to be given in 7th week of treatment (ie none with final 2 fractions).

01.04 A Randomised Trial of Pre-operative Radiotherapy for Stage T3 Adenocarcinoma of Rectum

Description:
Attending specialist and patient decide whether certain or uncertain that pre-operative RT indicated. Patients whom it is considered certain (Group A) will be randomised to either Short Course (SC) pre-op RT or Long Course (LC) pre-op RT with concurrent chemotherapy. Patients whom it is considered uncertain (Group B) will be randomised either to initial surgery, SC or LC.

99.03 A Randomised Multicentre Trial of Involved Field Radiotherapy Versus Involved Field Radiotherapy Plus Chemotherapy for Stage I-II Low Grade Follicular Lymphoma

Description:
There are 2 arms of treatment. Patient randomised to receive either involved field radiotherapy plus 6 courses of chemotherapy or involved field radiotherapy only. Study will recruit 200 patients. Chemotherapy should begin 4 weeks after completion of RT. Follow-up at 3-monthly intervals x 2 years, then 6-monthly until 5 years, then annually.

99.04 A Prospective, Non-Randomised Study of Chemotherapy and Radiotherapy for Osteolymphoma (OL).

Description:
Chemotherapy – 3 cycles over 3 weeks: cyclophosphamide, doxorubicin, vincristine plus a steroid (prednisolone).
Radiotherapy – starts 3 weeks after last cycle of chemotherapy for 5 weeks.

99.05 Tumour Volume as an Independent Prognostic Factor in Patients with Non-Small Cell Lung Cancer: a Protocol for a Prospective Database.

Description:
Determine in patients with locoregional NSCLCA treated by definite RT the influence on survival of the volume of the primary tumour measured from CT imaging after adjusting effect of current TNM staging and other known prognostic factors (ECOG and weight loss).

EORTC Trials

EORTC 15011-30011 An International Field Study of the Reliability and Validity of the EORTC QLQ-C30 and a Disease-Specific Questionnaire Module (QLQ-PR25) for Assessing Quality of Life of Patients with Prostate Cancer.