Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000041459
Ethics application status
Approved
Date submitted
22/12/2003
Date registered
22/12/2003
Date last updated
12/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy study of adding chemotherapy to radiotherapy for treating bladder cancer
Scientific title
Trans Tasman Radiation Oncology Group (TROG) 02.03 - Multicentre Phase III study comparing Radical Synchronous Chemo-Radiation (cisplatin) vs Radical Radiation Alone in the Definitive Management of Muscle Invasive Transitional Cell Carcinoma (TCC) of the Urinary Bladder Following Maximal Trans-Urethral Resection to reduce invasive local failure.
Secondary ID [1] 47 0
ClinicalTrials.gov: NCT00330499
Secondary ID [2] 48 0
National Clinical Trials Registry: NCTR476
Universal Trial Number (UTN)
Trial acronym
TROG 02.03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transitional Cell Carcinoma of Urinary bladder 44 0
Condition category
Condition code
Cancer 51 51 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM A: Synchronous chemo/radiation therapy. Weekly infusional cisplatin 35mg/m sqaured x 6 doses plus radiation 64Gy/32 fractions over 6 1/2 weeks.
Intervention code [1] 1301 0
Treatment: Drugs
Comparator / control treatment
ARM B: Radiation alone. 64Gy/32 fractions over 6 1/2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 84 0
Invasive local failure
Timepoint [1] 84 0
At 3 years
Secondary outcome [1] 162 0
1. Complete response rate
Timepoint [1] 162 0
At 3mths from randomisation.
Secondary outcome [2] 163 0
2. Disease free survival.
Timepoint [2] 163 0
Time from randomisation to failure or death. Measured until death.
Secondary outcome [3] 164 0
3. Overall survival.
Timepoint [3] 164 0
Time from randomisation to death from any cause. Measured unitl death.
Secondary outcome [4] 165 0
4. Acute and late toxicity.
Timepoint [4] 165 0
Measured every 3 months for the first yr, 6 monthly until 3 yrs and then yearly until death.
Secondary outcome [5] 166 0
5. Pattern of failure. Local failure, regioanl failure, distant failure and death are anaylsed.
Timepoint [5] 166 0
Measured every 3 months for the first yr, 6 monthly until 3 yrs and then yearly until death.
Secondary outcome [6] 167 0
6. Quality of Life measures.
Timepoint [6] 167 0
Measured pre treatment, week 7 at the end of treatment, 3mths, 12 months post treatment and 2 years post treatment.

Eligibility
Key inclusion criteria
1. Histologically proven Transitional Cell Carcinoma (TCC) of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.
2. 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.
3. Maximal Trans Urethral Resection (TUR). N.B. Previous: a) partial cystectomy; b) endoscopic resection of bladder tumour/s; c) intravesical chemotherapy; or d) intravesical Bacillus Calmette-Guerin (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).
4. Creatinine clearance >= 50ml/minute by calculation or measurement.
5. A white blood cell count >= 3.5 x 109/L with an absolute neutrophil count >= 1.5 x 109/L and a platelet count >= 100 x 109/L
6. Eastern Cooperative Oncology Group status of 0, 1 or 2.
7. No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up.
8. 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
1. Pure squamous carcinomas or adenocarcinomas.
2. Extensive or multifocal Carcinoma In Situ (CIS) change in the bladder.
3. T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease.
4. Presence of ureteric obstruction due to tumour infiltration at the Ureteral Orifice (UO) not amenable to stenting.
5. Previous radiation treatment to the pelvis.
6. Previous significant pelvic surgery.
7. Significant bowel or gynaecological inflammatory disease.
8. Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 109/L with an absolute neutrophil count < 1.5 x 109L and/or a platelet count < 100 x 109/L.
9. Other considerations making patient unfit for Cisplatin therapy.
10. 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 b) In situ carcinoma of the cervix in women.
11. 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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Factors: Stage T2/T3/T4a, Complete Trans Urethral resection only, Centre. Simple randomisation by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/10/2002
Actual
11/10/2002
Date of last participant enrolment
Anticipated
Actual
11/11/2007
Date of last data collection
Anticipated
Actual
9/02/2010
Sample size
Target
150
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment outside Australia
Country [1] 386 0
New Zealand
State/province [1] 386 0

Funding & Sponsors
Funding source category [1] 73 0
Government body
Name [1] 73 0
National Health & Medical Research Council Project Grant
Country [1] 73 0
Australia
Primary sponsor type
Individual
Name
Kumar Gogna
Address
Mater QRI Raymond Terrace SOUTH BRISBANE QLD 4101
Country
Australia
Secondary sponsor category [1] 59 0
Other Collaborative groups
Name [1] 59 0
Trans Tasman Radiation Oncology Group (TROG)
Address [1] 59 0
Edith St Waratah NSW 2298
Country [1] 59 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 542 0
William Buckland radiotherapy Centre, The Alfred
Ethics committee address [1] 542 0
Ethics committee country [1] 542 0
Australia
Date submitted for ethics approval [1] 542 0
Approval date [1] 542 0
31/05/2002
Ethics approval number [1] 542 0
Ethics committee name [2] 543 0
Auckland Hospital
Ethics committee address [2] 543 0
Ethics committee country [2] 543 0
New Zealand
Date submitted for ethics approval [2] 543 0
Approval date [2] 543 0
Ethics approval number [2] 543 0
Ethics committee name [3] 544 0
Campbelltown Hospital
Ethics committee address [3] 544 0
Ethics committee country [3] 544 0
Australia
Date submitted for ethics approval [3] 544 0
Approval date [3] 544 0
Ethics approval number [3] 544 0
Ethics committee name [4] 545 0
Christchurch Hospital
Ethics committee address [4] 545 0
Ethics committee country [4] 545 0
New Zealand
Date submitted for ethics approval [4] 545 0
Approval date [4] 545 0
Ethics approval number [4] 545 0
Ethics committee name [5] 546 0
Dunedin Hospital
Ethics committee address [5] 546 0
Ethics committee country [5] 546 0
New Zealand
Date submitted for ethics approval [5] 546 0
Approval date [5] 546 0
Ethics approval number [5] 546 0
Ethics committee name [6] 547 0
Premion Tugun
Ethics committee address [6] 547 0
Ethics committee country [6] 547 0
Australia
Date submitted for ethics approval [6] 547 0
Approval date [6] 547 0
Ethics approval number [6] 547 0
Ethics committee name [7] 548 0
Andrew Love Cancer centre, Geelong Hospital
Ethics committee address [7] 548 0
Ethics committee country [7] 548 0
Australia
Date submitted for ethics approval [7] 548 0
Approval date [7] 548 0
Ethics approval number [7] 548 0
Ethics committee name [8] 549 0
Launceston Hospital
Ethics committee address [8] 549 0
Ethics committee country [8] 549 0
Australia
Date submitted for ethics approval [8] 549 0
Approval date [8] 549 0
Ethics approval number [8] 549 0
Ethics committee name [9] 550 0
Liverpool Hospital
Ethics committee address [9] 550 0
Ethics committee country [9] 550 0
Australia
Date submitted for ethics approval [9] 550 0
Approval date [9] 550 0
Ethics approval number [9] 550 0
Ethics committee name [10] 551 0
Mater QRI
Ethics committee address [10] 551 0
Ethics committee country [10] 551 0
Australia
Date submitted for ethics approval [10] 551 0
Approval date [10] 551 0
Ethics approval number [10] 551 0
Ethics committee name [11] 552 0
Nepean Hospital
Ethics committee address [11] 552 0
Ethics committee country [11] 552 0
Australia
Date submitted for ethics approval [11] 552 0
Approval date [11] 552 0
Ethics approval number [11] 552 0
Ethics committee name [12] 553 0
Calvary Mater Newcastle
Ethics committee address [12] 553 0
Ethics committee country [12] 553 0
Australia
Date submitted for ethics approval [12] 553 0
Approval date [12] 553 0
Ethics approval number [12] 553 0
Ethics committee name [13] 554 0
Palmerston North
Ethics committee address [13] 554 0
Ethics committee country [13] 554 0
Australia
Date submitted for ethics approval [13] 554 0
Approval date [13] 554 0
Ethics approval number [13] 554 0
Ethics committee name [14] 555 0
Peter MacCallum Cancer Centre
Ethics committee address [14] 555 0
Ethics committee country [14] 555 0
Australia
Date submitted for ethics approval [14] 555 0
Approval date [14] 555 0
Ethics approval number [14] 555 0
Ethics committee name [15] 556 0
Prince of Wales Hospital
Ethics committee address [15] 556 0
Ethics committee country [15] 556 0
Australia
Date submitted for ethics approval [15] 556 0
Approval date [15] 556 0
Ethics approval number [15] 556 0
Ethics committee name [16] 557 0
Royal Adelaide Hospital
Ethics committee address [16] 557 0
Ethics committee country [16] 557 0
Australia
Date submitted for ethics approval [16] 557 0
Approval date [16] 557 0
Ethics approval number [16] 557 0
Ethics committee name [17] 558 0
Royal Brisbane and Women's Hospital
Ethics committee address [17] 558 0
Ethics committee country [17] 558 0
Australia
Date submitted for ethics approval [17] 558 0
Approval date [17] 558 0
Ethics approval number [17] 558 0
Ethics committee name [18] 559 0
Royal Perth Hospital
Ethics committee address [18] 559 0
Ethics committee country [18] 559 0
Australia
Date submitted for ethics approval [18] 559 0
Approval date [18] 559 0
Ethics approval number [18] 559 0
Ethics committee name [19] 560 0
Sir Charles Gairdner Hospital
Ethics committee address [19] 560 0
Ethics committee country [19] 560 0
Australia
Date submitted for ethics approval [19] 560 0
Approval date [19] 560 0
Ethics approval number [19] 560 0
Ethics committee name [20] 561 0
Wellington Hospital
Ethics committee address [20] 561 0
Ethics committee country [20] 561 0
New Zealand
Date submitted for ethics approval [20] 561 0
Approval date [20] 561 0
Ethics approval number [20] 561 0
Ethics committee name [21] 562 0
Westmead Hospital
Ethics committee address [21] 562 0
Ethics committee country [21] 562 0
Australia
Date submitted for ethics approval [21] 562 0
Approval date [21] 562 0
Ethics approval number [21] 562 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35697 0
Dr Kumar Gogna
Address 35697 0
Queensland Radium Institute-Mater Centre
Raymond Terrace
South Brisbane, Queensland, 4101, Australia
Country 35697 0
Australia
Phone 35697 0
+61 7 3840 3255
Fax 35697 0
Email 35697 0
Kumar.Gogna@health.qld.gov.au
Contact person for public queries
Name 10490 0
Kacy Baumann
Address 10490 0
Mater QRI
Raymond Terrace
South Brisbane QLD 4101
Country 10490 0
Australia
Phone 10490 0
+61 7 3840 3219
Fax 10490 0
Email 10490 0
Kacy_Baumann@health.qld.gov.au
Contact person for scientific queries
Name 1418 0
Kumar Gogna
Address 1418 0
Mater QRI
Raymond Terrace
SOUTH BRISBANE QLD 4101
Country 1418 0
Australia
Phone 1418 0
+61 7 3840 3255
Fax 1418 0
Email 1418 0
Kumar_Gogna@health.qld.gov.au

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