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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Other TROG 02.03 NHMRC 243100, NCT00330499

Trial Description

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 superior to radiotherapy alone.

Further Study Information

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).

Eligibility Criteria

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:

1. partial cystectomy;

2. endoscopic resection of bladder tumour/s;

3. intravesical chemotherapy; or

4. 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:

1. non-melanoma skin cancer, and/or

2. (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

Trial Contact Information

Trial Lead Organizations/Sponsors

Trans-Tasman Radiation Oncological Group Incorporated

Kumar Gogna

Study Chair

Kumar Gogna		Ph: 07 3840 3255
		Email: Kumar_Gogna@health.qld.gov.au

Australia
	Nedlands
	Sir Charles Gairdner Hospital - Perth
	Perth
	Royal Perth Hospital
New South Wales
	Liverpool
	Cancer Therapy Centre at Liverpool Hospital
	Newcastle
	Newcastle Mater Misericordiae Hospital
	Penrith
	Nepean Cancer Care Centre at Nepean Hospital
	Randwick
	Prince of Wales Private Hospital
	Wentworthville
	Westmead Institute for Cancer Research at Westmead Hospital
Queensland
	Brisbane
	Mater Adult Hospital
	Herston
	Royal Brisbane and Women's Hospital
	Tugun
	East Coast Cancer Centre - Tugun
South Australia
	Adelaide
	Royal Adelaide Hospital Cancer Centre
Tasmania
	Launceston
	Launceston General Hospital
Victoria
	East Melbourne
	Peter MacCallum Cancer Centre
	Geelong
	Andrew Love Cancer Centre
	Prahran
	Alfred Hospital
New Zealand
	Auckland
	Auckland City Hospital
	Christchurch
	Christchurch Hospital
	Dunedin
	Dunedin Hospital
	Palmerston North
	Palmerston North Hospital
	Wellington
	Wellington Cancer Centre

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00330499
Information obtained from ClinicalTrials.gov on May 27, 2008