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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00330499




Registration number
NCT00330499
Ethics application status
Date submitted
25/05/2006
Date registered
26/05/2006
Date last updated
12/07/2017

Titles & IDs
Public title
Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.
Scientific title
A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder
Secondary ID [1] 0 0
NHMRC 243100
Secondary ID [2] 0 0
TROG 02.03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transitional Cell Carcinoma of Urinary Bladder 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cisplatin
Treatment: Other - External beam radiation treatment

Experimental: A - Synchronous chemo / radiation therapy

Active comparator: B - Radiation Alone


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

Treatment: Other: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive local failure at 3 years
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Complete response (CR) rate at 3 months from randomisation
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Disease-free survival
Timepoint [2] 0 0
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Secondary outcome [4] 0 0
Cystectomy-free survival
Timepoint [4] 0 0
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Secondary outcome [5] 0 0
Acute and late toxicity
Timepoint [5] 0 0
Interim analyses will be performed on an annual basis.
Secondary outcome [6] 0 0
Pattern of failure (local, regional, distant)
Timepoint [6] 0 0
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Secondary outcome [7] 0 0
Quality of life measures
Timepoint [7] 0 0
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Newcastle - Newcastle
Recruitment hospital [3] 0 0
Nepean Cancer Care Centre - Penrith
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [6] 0 0
Mater Centre - South Brisbane - Brisbane
Recruitment hospital [7] 0 0
Townsville Hospital - Douglas
Recruitment hospital [8] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [9] 0 0
East Coast Cancer Centre - Tugun
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [13] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [14] 0 0
Andrew Love Cancer Care Centre, Geelong Hospital - Geelong
Recruitment hospital [15] 0 0
Alfred Hospital - Prahran
Recruitment hospital [16] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [17] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2751 - Penrith
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Wentworthville
Recruitment postcode(s) [6] 0 0
4120 - Brisbane
Recruitment postcode(s) [7] 0 0
4814 - Douglas
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
4224 - Tugun
Recruitment postcode(s) [10] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
7250 - Launceston
Recruitment postcode(s) [13] 0 0
3002 - East Melbourne
Recruitment postcode(s) [14] 0 0
3220 - Geelong
Recruitment postcode(s) [15] 0 0
3181 - Prahran
Recruitment postcode(s) [16] 0 0
6009 - Nedlands
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Dunedin
Country [4] 0 0
New Zealand
State/province [4] 0 0
Palmerston North
Country [5] 0 0
New Zealand
State/province [5] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00330499
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kumar Gogna
Address 0 0
Mater Centre - South Brisbane
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00330499