Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.
A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder
研究概览
地位
详细说明
Whilst concurrent chemo-radiation is increasingly being looked upon as the treatment of choice for patients referred for bladder preservation, the study by the NCI of Canada (Coppin CM, Gospodarowicz MK et al.Improved Local Control of Invasive Bladder Cancer by Concurrent Cisplatin and Pre-operative or Definitive Radiation.J. of Clinical Oncol. 14(11): 2901-2907, 1996) is the only randomised trial to show some superiority of concurrent Cisplatin and radiation treatment over radiation alone in increasing pelvic tumour control. There was no impact on overall survival. However, this study had relatively small subject numbers and included two distinct treatment options. In one group the patients were treated with a bladder sparing approach and in the other by pre-operative therapy and cystectomy with the type of definitive treatment being decided upon by both the treating Specialist and patient. At 5 years the pelvic failure rates in the radiation alone and chemo-radiation arms were 59% and 40% respectively. With half of the patients in each group having had planned cystectomy as part of their treatment regimen, the above rates of local relapse (especially in the chemo-radiation arm) are disappointing.
Given the concerns with the above study, and the continuing paucity of randomised phase III studies comparing chemo-radiation with radiation alone, there lies an opportunity for Australasian centres to take up the challenge. For this study, the proposed schedule for the chemo-radiation arm is to be the same as that being investigated in our previous phase II study (six weekly doses of Cisplatin plus radiation to a dose of 64Gy in 32 fractions over 6.5 weeks). This will be compared with radical radiation alone (64Gy in 32 fractions over 6.5 weeks).
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Auckland、新西兰、1001
- Auckland Hospital
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Christchurch、新西兰、4710
- Christchurch Hospital
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Dunedin、新西兰
- Dunedin Hospital
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Palmerston North、新西兰
- Palmerston North Hospital
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Wellington、新西兰、7902
- Wellington Hospital
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New South Wales
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Liverpool、New South Wales、澳大利亚、1871
- Liverpool Hospital
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Newcastle、New South Wales、澳大利亚、2298
- Calvary Mater Newcastle
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Penrith、New South Wales、澳大利亚、2751
- Nepean Cancer Care Centre
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Randwick、New South Wales、澳大利亚、2031
- Prince of Wales Hospital
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Wentworthville、New South Wales、澳大利亚、2145
- Westmead Hospital
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Queensland
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Brisbane、Queensland、澳大利亚、4120
- Mater Centre - South Brisbane
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Douglas、Queensland、澳大利亚、4814
- Townsville Hospital
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Herston、Queensland、澳大利亚、4029
- Royal Brisbane Hospital
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Tugun、Queensland、澳大利亚、4224
- East Coast Cancer Centre
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Woolloongabba、Queensland、澳大利亚、4102
- Princess Alexandra Hospital
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South Australia
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Adelaide、South Australia、澳大利亚、5000
- Royal Adelaide Hospital
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Tasmania
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Launceston、Tasmania、澳大利亚、7250
- Launceston General Hospital
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Victoria
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East Melbourne、Victoria、澳大利亚、3002
- Peter MacCallum Cancer Centre
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Geelong、Victoria、澳大利亚、3220
- Andrew Love Cancer Care Centre, Geelong Hospital
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Prahran、Victoria、澳大利亚、3181
- Alfred Hospital
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Western Australia
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Nedlands、Western Australia、澳大利亚、6009
- Sir Charles Gairdner Hospital
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Perth、Western Australia、澳大利亚、6000
- Royal Perth Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Histologically proven TCC of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.
- Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm in maximum dimension), N0, M0.
If radiological evaluation of a lymph node is interpreted as "positive" this must be evaluated further by either lymph node sampling or percutaneous needle biopsy. Patients with histologically confirmed lymph node metastases will not be eligible.
- Maximal TUR.
N.B. Previous:
- partial cystectomy;
- endoscopic resection of bladder tumour/s;
- intravesical chemotherapy; or
- intravesical BCG
does not exclude the patient from being eligible. However, the patient should have an adequate functioning bladder (this should be clarified with the referring Urologist and if need be voiding volumes should be measured).
- Creatinine clearance >= 50ml/minute by calculation or measurement.
- A white blood cell count >= 3.5 x 10^9/L with an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.
- ECOG status of 0, 1 or 2.
- No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up.
- No significant intercurrent morbidity.
Exclusion Criteria:
- Pure squamous carcinomas or adenocarcinomas.
- Extensive or multifocal CIS change in the bladder.
- T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease.
- Presence of ureteric obstruction due to tumour infiltration at the UO not amenable to stenting.
- Previous radiation treatment to the pelvis.
- Previous significant pelvic surgery.
- Significant bowel or gynaecological inflammatory disease.
- Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 10^9/L with an absolute neutrophil count < 1.5 x 10^9L and/or a platelet count < 100 x 10^9/L.
- Other considerations making patient unfit for Cisplatin therapy.
Prior or concurrent malignancy of any other site unless disease-free for greater than 5 years, except for:
- non-melanoma skin cancer, and/or
- (a) Stage T1 well differentiated prostatic carcinoma in men, and In situ carcinoma of the cervix in women.
- Bladder tumour - biopsy only. These patients must be referred back for more adequate resections or else should not be included
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:A
Synchronous chemo / radiation therapy
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Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
其他名称:
64Gy reference dose in 32 fractions over 6.5 weeks
其他名称:
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有源比较器:B
Radiation Alone
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64Gy reference dose in 32 fractions over 6.5 weeks
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Invasive local failure at 3 years
大体时间:3 years
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3 years
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次要结果测量
结果测量 |
大体时间 |
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Complete response (CR) rate at 3 months from randomisation
大体时间:3 months
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3 months
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Disease-free survival
大体时间:Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Overall survival
大体时间:Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Cystectomy-free survival
大体时间:Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Acute and late toxicity
大体时间:Interim analyses will be performed on an annual basis.
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Interim analyses will be performed on an annual basis.
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Pattern of failure (local, regional, distant)
大体时间:Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Quality of life measures
大体时间:Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
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合作者和调查者
调查人员
- 学习椅:Kumar Gogna、Mater Centre - South Brisbane
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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