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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12610000711011 | Registry Identifier | Austalian New Zealand Clinical Trial Regisrty |
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The principal objective of the trial is to test the hypothesis that Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation Oncology departments.
This is a single-arm multicentre feasibility trial in which the primary aim is to determine the compliance rate of patients to online adaptive radiotherapy for muscle invasive bladder cancer over multiple Australian and New Zealand centres. The compliance rate is defined as the proportion of patients successfully completing treatment without a major protocol deviation.
Subject to the accrual being at least 40 patients in the first 2 years, accrual will continue until a total of 50 patients have been accrued. If this accrual target is not met, then consideration will be given to stopping the trial early due to poor accrual. Each patient will be followed-up until 2 years after the last patient's date of accrual. Assessments for toxicity and recurrence or progression will take place at four weeks after completion of treatment, then three monthly from the end of treatment for the first 12 months and then 6 monthly thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Radiation Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | A radical dose of radiotherapy to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 treatment days.
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| Measure | Description | Time Frame |
|---|---|---|
| Compliance with Online Adaptive Radiation Therapy process | A patient is considered to be compliant if that patient completes treatment without experiencing a major protocol deviation | From the start date of radiotherapy to the last day of radiotherapy treatment (approxiamately 6 weeks and 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pattern of failure and competing risks analysis | Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy. | From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Farshad Foroudi | Peter MacCallum Cancer Centre, Australia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Calvary Mater Newcastle |
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| Label | URL |
|---|---|
| Click here for more information about this study on the TROG official website | View source |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Disease Free survival |
Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy. |
| From date of enrolment, every three months after RT untill 24 months, then 6 monthly until the end of the trial |
| Acute Toxicity of >/= grade 3 (NCI CTCAE version 4.0) of gastointestinal, diarrhoea, nausea, vomiting, colitis, proctitis, renal/genitourinary, cyctitis non-infective, haematuria, uinary frequency, urinary urgency and urinary retension. | Patients will be assesed at baseline, weekly durning radiotherapy, then at one month and three months post radiotherapy. | From start date of radiotherapy and within 3 months of completion of radiation treatment |
| Quality of Life | Patients will be assessed at baseline, on the last day of radiotherapy, at one month post radiotherapy, then at 18 months follow up. | Within 2 weeks prior to commencement of treatment, during the last week of treatment, 1 and 18 months after the completion of treatment. |
| Late normal tissue effects | Patients will be assessed at 3 monts post radiotherapy, then every 3 months until 2 years post radiotherapy. | Between 3 months and 3 years after the completion of radiation treatment |
| Time to Local Bladder Failure | Patients will be assessed at baseline, weekly durning radiotherapy, 1 month post radiotherapy, then every three months until two years post radiotherapy. | From date of enrolment to date of local bladder failure |
| Newcastle |
| New South Wales |
| 2298 |
| Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Mater Hospital | Brisbane | Queensland | 4101 | Australia |
| Townsville Hospital | Douglas | Queensland | 4814 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| Peter MacCallum Cancer Centre - Box Hill | Melbourne | Victoria | 3128 | Australia |
| Peter MacCallum Cancer Centre - Morrabbin | Melbourne | Victoria | 3165 | Australia |
| Alfred Hospital | Prahran | Victoria | 3181 | Australia |
| Christchurch Hospital | Christchurch | 4710 | New Zealand |
| Waikato Hospital | Waikato | 3240 | New Zealand |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |