Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.

NCT ID: NCT00330499

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2010-02-28

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 superior to radiotherapy alone.

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 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).

Conditions

Transitional Cell Carcinoma of Urinary Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Synchronous chemo / radiation therapy

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Weekly Cisplatin 35mg/m2 x 6 doses, IV administration

External beam radiation treatment

Intervention Type: RADIATION

64Gy reference dose in 32 fractions over 6.5 weeks

B

Radiation Alone

Group Type: ACTIVE_COMPARATOR

External beam radiation treatment

Intervention Type: RADIATION

64Gy reference dose in 32 fractions over 6.5 weeks

Interventions

Cisplatin

Weekly Cisplatin 35mg/m2 x 6 doses, IV administration

Intervention Type: DRUG

External beam radiation treatment

64Gy reference dose in 32 fractions over 6.5 weeks

Intervention Type: RADIATION

Other Intervention Names

Cisplatuin Ebewe, Cisplatin Injection; Radiation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Trans Tasman Radiation Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kumar Gogna

Role: STUDY_CHAIR

Mater Centre - South Brisbane

Locations

Liverpool Hospital

Liverpool, New South Wales, Australia

Calvary Mater Newcastle

Newcastle, New South Wales, Australia

Nepean Cancer Care Centre

Penrith, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Westmead Hospital

Wentworthville, New South Wales, Australia

Mater Centre - South Brisbane

Brisbane, Queensland, Australia

Townsville Hospital

Douglas, Queensland, Australia

Royal Brisbane Hospital

Herston, Queensland, Australia

East Coast Cancer Centre

Tugun, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Launceston General Hospital

Launceston, Tasmania, Australia

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Andrew Love Cancer Care Centre, Geelong Hospital

Geelong, Victoria, Australia

Alfred Hospital

Prahran, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Auckland Hospital

Auckland, , New Zealand

Christchurch Hospital

Christchurch, , New Zealand

Dunedin Hospital

Dunedin, , New Zealand

Palmerston North Hospital

Palmerston North, , New Zealand

Wellington Hospital

Wellington, , New Zealand

Countries

Australia; New Zealand

Related Links

http://www.trog.com.au

Click here for more information about this study on the TROG official website

Other Identifiers

NHMRC 243100

Identifier Type: -

Identifier Source: secondary_id

TROG 02.03

Identifier Type: -

Identifier Source: org_study_id