Status:
COMPLETED
Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.
Lead Sponsor:
Trans Tasman Radiation Oncology Group
Collaborating Sponsors:
National Health and Medical Research Council, Australia
Conditions:
Transitional Cell Carcinoma of Urinary Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 superio...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00330499
Start Date
October 1 2002
End Date
February 1 2010
Last Update
July 12 2017
Active Locations (22)
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1
Liverpool Hospital
Liverpool, New South Wales, Australia, 1871
2
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
3
Nepean Cancer Care Centre
Penrith, New South Wales, Australia, 2751
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031