Transitional Cell Carcinoma of Urinary Bladder Clinical Trial
Official title:
A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder
The purpose of this study is to define the optimal management of localised transitional cell carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether chemoradiation is superior to radiotherapy alone.
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).
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