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
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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New South Wales
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Liverpool、New South Wales、オーストラリア、1871
- Liverpool Hospital
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Newcastle、New South Wales、オーストラリア、2298
- Calvary Mater Newcastle
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Penrith、New South Wales、オーストラリア、2751
- Nepean Cancer Care Centre
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Randwick、New South Wales、オーストラリア、2031
- Prince of Wales Hospital
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Wentworthville、New South Wales、オーストラリア、2145
- Westmead Hospital
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Queensland
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Brisbane、Queensland、オーストラリア、4120
- Mater Centre - South Brisbane
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Douglas、Queensland、オーストラリア、4814
- Townsville Hospital
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Herston、Queensland、オーストラリア、4029
- Royal Brisbane Hospital
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Tugun、Queensland、オーストラリア、4224
- East Coast Cancer Centre
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Woolloongabba、Queensland、オーストラリア、4102
- Princess Alexandra Hospital
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- Royal Adelaide Hospital
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Tasmania
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Launceston、Tasmania、オーストラリア、7250
- Launceston General Hospital
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Victoria
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East Melbourne、Victoria、オーストラリア、3002
- Peter MacCallum Cancer Centre
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Geelong、Victoria、オーストラリア、3220
- Andrew Love Cancer Care Centre, Geelong Hospital
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Prahran、Victoria、オーストラリア、3181
- Alfred Hospital
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Western Australia
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Nedlands、Western Australia、オーストラリア、6009
- Sir Charles Gairdner Hospital
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Perth、Western Australia、オーストラリア、6000
- Royal Perth Hospital
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Auckland、ニュージーランド、1001
- Auckland Hospital
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Christchurch、ニュージーランド、4710
- Christchurch Hospital
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Dunedin、ニュージーランド
- Dunedin Hospital
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Palmerston North、ニュージーランド
- Palmerston North Hospital
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Wellington、ニュージーランド、7902
- Wellington Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：A
Synchronous chemo / radiation therapy
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Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
他の名前：
64Gy reference dose in 32 fractions over 6.5 weeks
他の名前：
|
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アクティブコンパレータ：B
Radiation Alone
|
64Gy reference dose in 32 fractions over 6.5 weeks
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Invasive local failure at 3 years
時間枠：3 years
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3 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Complete response (CR) rate at 3 months from randomisation
時間枠：3 months
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3 months
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Disease-free survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Kumar Gogna、Mater Centre - South Brisbane
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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